Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions

An Open Label, Balanced, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single Oral Dose, Full Replicate Crossover, Bioequivalence Study of Albendazole Tablets IP 400 mg of Biddle Sawyer Limited (GSK Group Company) With Albendazole Tablets 400 mg of Glaxo SmithKline Consumer Healthcare, South Africa (PTY) Ltd in Healthy, Adult Participants Under Fed Condition

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06201559

Enrollment

Registered

2024-01-11

Start date

2023-08-21

Completion date

2023-09-12

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Diseases

Keywords

Albendazole, Bioequivalence

Brief summary

The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.

Interventions

DRUGAlbendazole IP 400 mg

Albendazole IP 400 mg tablets will be administered under fed conditions

DRUGAlbendazole 400 mg

Albendazole 400 mg tablets will be administered under fed conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy, non-smoker, adult participants having body mass index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kilogram (kg)/ height in meter square (m2) 2. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead electrocardiogram (ECG) and X-ray chest (postero-anterior view) recordings. 3. Able to understand and adhere to the study procedures 4. Voluntary written informed consent is given for study participation 5. In case of female participants: Surgically sterilized at least 6 months prior to study participation;Or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study, And Serum pregnancy test must be negative.

Exclusion criteria

1. Known hypersensitivity or idiosyncratic reaction to albendazole or any excipients or any related drug or any substance. 2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. 3. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or non-steroidal anti inflammatory drugs (NSAIDs) induced urticaria. 4. History or presence of seizure or psychiatric disorders. 5. Ingestion of a medication (prescribed medication & over the counter (OTC) medication, herbal remedies, cimetidine, praziquantel, dexamethasone, ritonavir, phenytoin, carbamazepine, phenobarbital) at any time in 14 days prior to dosing and any vaccine (including COVID-19 vaccine) from 14 days prior to dosing. In any such case participant selection will be at the discretion of the Principal Investigator. 6. Receipt of an intervention or participation in a drug research study within a period of 90 days prior to the first dose of study intervention \*\*. * If intervention is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of intervention received. 7. A positive hepatitis screen including hepatitis B surface antigen and/or hepatitis C virus (HCV) antibodies. 8. A positive test result for HIV antibody (1 and/or 2). 9. The presence of clinically significant abnormal laboratory values during screening.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Plasma Concentration (Cmax) of Albendazole	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.

Secondary

Measure	Time frame	Description
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Up to 22 days	A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.
Absolute Values of Vital Signs: Respiratory Rate	At screening, after check-in and before check-out in each period (each period is of 1 day)	Respiratory rate was collected in sitting position.
Absolute Values of Vital Signs: Radial Pulse	At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period (each period is of 1 day)	Radial pulse was collected in sitting position.
Change From Baseline in Vital Signs: Blood Pressure	Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period	Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.
Change From Baseline in Vital Signs: Respiratory Rate	After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)	Respiratory rate was collected in sitting position.
Change From Baseline in Vital Signs: Radial Pulse	pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period	Radial pulse was collected in sitting position.
Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period	Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.
Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide	Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours	Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

Countries

India

Participant flow

Participants by arm

Arm	Count
Test(T) Albendazole vs Reference(R) Albendazole First,Then (T) Albendazole vs (R) Albendazole (TRTR) Participants were orally administered with Albendazole \[Indian Pharmacopoeia (IP)\] 400 mg (T1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole 400 mg (R1) tablet in Period 2, then single dose Albendazole IP 400 mg (T2) tablet in Period 3 further followed by single dose Albendazole 400 mg (R2) tablet in Period 4	35
(R) Albendazole vs (T) Albendazole First,Then (R) Albendazole vs (T) Albendazole (RTRT) Participants were orally administered with Albendazole 400 mg (R1) tablet as single dose treatment under fed conditions on Day 1 in Period 1, followed by single dose of Albendazole IP 400 mg (T1) tablet in Period 2, then single dose Albendazole 400 mg (R2) tablet in Period 3 further followed by single dose Albendazole IP 400 mg (T2) tablet in Period 4	35
Total	70

Baseline characteristics

Characteristic	(R) Albendazole vs (T) Albendazole First,Then (R) Albendazole vs (T) Albendazole (RTRT)	Total	Test(T) Albendazole vs Reference(R) Albendazole First,Then (T) Albendazole vs (R) Albendazole (TRTR)
Age, Continuous	34.5 Years STANDARD_DEVIATION 6.4	33.2 Years STANDARD_DEVIATION 5.94	32 Years STANDARD_DEVIATION 5.25
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	35 Participants	70 Participants	35 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	4 Participants	8 Participants	4 Participants
Sex: Female, Male Male	31 Participants	62 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 67	0 / 68
other Total, other adverse events	6 / 67	6 / 68
serious Total, serious adverse events	1 / 67	0 / 68

Outcome results

Primary

Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole

Blood samples were collected for PK analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Population: PK population. As pre-specified in the Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), Reference Study Intervention-R1 (1st administration) and Reference Study Intervention-R2 (2nd administration). Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole	179.419 Nanogramhour/ milliliter (ngh/mL)	Geometric Coefficient of Variation 129.5
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole	164.052 Nanogramhour/ milliliter (ngh/mL)	Geometric Coefficient of Variation 120.4
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole	161.034 Nanogramhour/ milliliter (ngh/mL)	Geometric Coefficient of Variation 127.4
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole	182.792 Nanogramhour/ milliliter (ngh/mL)	Geometric Coefficient of Variation 117.2

90% CI: [86.86, 109.73]

Primary

Maximum Plasma Concentration (Cmax) of Albendazole

Blood samples were collected for pharmacokinetic (PK) analysis of Albendazole. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Population: PK population included all participants in Safety set who had at least 1 measurable PK assessment. As pre-specified in Statistical Analysis Plan (SAP), data is collected and reported for PK parameters per study intervention i.e. Test Study Intervention-T1 (1st administration), Test Study Intervention-T2 (2nd administration), and Reference Study Intervention-R1 and Reference Study Intervention-R2 similarly. Only those participants with data available at specified time points have been analyzed.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Maximum Plasma Concentration (Cmax) of Albendazole	43.846 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 114.1
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Maximum Plasma Concentration (Cmax) of Albendazole	41.685 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 110.9
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Maximum Plasma Concentration (Cmax) of Albendazole	39.737 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 112.1
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Maximum Plasma Concentration (Cmax) of Albendazole	46.115 nanogram/millilitre (ng/mL)	Geometric Coefficient of Variation 102.6

90% CI: [86.79, 110.91]

Secondary

Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)

Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.

Time frame: At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours (Hrs) post-dose in each period

Population: Safety Population. As pre-specified in SAP, data for safety was collected and reported across two treatment groups as participants were randomized in either of the two treatment sequences (TRTR or RTRT) at the start of the study and they remained in the same sequence until end of the study. Each participant was counted once throughout the study for this analysis.

Arm	Measure	Group	Value (MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, Pre-dose	76.1 millimeters of mercury (mmHg)	Standard Deviation 4.17
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 24 Hrs Post Dose	116.7 millimeters of mercury (mmHg)	Standard Deviation 3.29
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 2 Hrs Post Dose	74.8 millimeters of mercury (mmHg)	Standard Deviation 3.47
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 6 Hrs Post Dose	73.4 millimeters of mercury (mmHg)	Standard Deviation 5.2
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, 24 Hrs Post Dose	76.2 millimeters of mercury (mmHg)	Standard Deviation 3.52
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, Pre-dose	113.9 millimeters of mercury (mmHg)	Standard Deviation 4.5
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, Pre-Dose	78.9 millimeters of mercury (mmHg)	Standard Deviation 3.17
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, 4 Hrs Post Dose	70.3 millimeters of mercury (mmHg)	Standard Deviation 4.13
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, 2 Hrs Post Dose	73.6 millimeters of mercury (mmHg)	Standard Deviation 5.56
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 2 Hrs Post Dose	120.3 millimeters of mercury (mmHg)	Standard Deviation 4.64
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, 4 Hrs Post Dose	76.3 millimeters of mercury (mmHg)	Standard Deviation 5.47
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 24 Hrs Post Dose	76.2 millimeters of mercury (mmHg)	Standard Deviation 3.71
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, 6 Hrs Post Dose	75.1 millimeters of mercury (mmHg)	Standard Deviation 6.18
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 2 Hrs Post Dose	114.2 millimeters of mercury (mmHg)	Standard Deviation 4.14
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3,12 Hrs Post Dose	75.0 millimeters of mercury (mmHg)	Standard Deviation 4.49
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, 6 Hrs Post Dose	74.5 millimeters of mercury (mmHg)	Standard Deviation 2.29
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, 24 Hrs Post Dose	75.9 millimeters of mercury (mmHg)	Standard Deviation 2.8
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 4 Hrs Post Dose	115.9 millimeters of mercury (mmHg)	Standard Deviation 3.88
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, Pre-Dose	76.3 millimeters of mercury (mmHg)	Standard Deviation 3.47
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 4 Hrs Post Dose	74.6 millimeters of mercury (mmHg)	Standard Deviation 4.41
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 2 Hrs Post Dose	72.5 millimeters of mercury (mmHg)	Standard Deviation 4.79
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 6 Hrs Post Dose	115.0 millimeters of mercury (mmHg)	Standard Deviation 4.4
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 12 Hrs Post Dose	74.3 millimeters of mercury (mmHg)	Standard Deviation 3.47
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2,12 Hrs Post Dose	70.7 millimeters of mercury (mmHg)	Standard Deviation 5.62
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 24 Hrs Post Dose	77.1 millimeters of mercury (mmHg)	Standard Deviation 2.46
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, Pre-dose	117.0 millimeters of mercury (mmHg)	Standard Deviation 3.18
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, Pre-dose	116.1 millimeters of mercury (mmHg)	Standard Deviation 3.53
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, Pre-Dose	72.9 millimeters of mercury (mmHg)	Standard Deviation 3.26
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 2 Hrs Post Dose	116.2 millimeters of mercury (mmHg)	Standard Deviation 3.46
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 2 Hrs Post Dose	116.6 millimeters of mercury (mmHg)	Standard Deviation 3.2
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 4 Hrs Post Dose	116.3 millimeters of mercury (mmHg)	Standard Deviation 4.51
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 4 Hrs Post Dose	74.1 millimeters of mercury (mmHg)	Standard Deviation 2.61
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 6 Hrs Post Dose	117.3 millimeters of mercury (mmHg)	Standard Deviation 4.6
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 4 Hrs Post Dose	116.6 millimeters of mercury (mmHg)	Standard Deviation 3.91
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 12 Hrs Post Dose	73.9 millimeters of mercury (mmHg)	Standard Deviation 5.22
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 4 Hrs Post Dose	119.4 millimeters of mercury (mmHg)	Standard Deviation 2.55
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 6 Hrs Post Dose	118.3 millimeters of mercury (mmHg)	Standard Deviation 3.43
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 6 Hrs Post Dose	117.5 millimeters of mercury (mmHg)	Standard Deviation 3.9
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 6 Hrs Post Dose	73.2 millimeters of mercury (mmHg)	Standard Deviation 2.86
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 12 Hrs Post Dose	118.6 millimeters of mercury (mmHg)	Standard Deviation 4.45
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 12 Hrs Post Dose	116.3 millimeters of mercury (mmHg)	Standard Deviation 3.69
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 24 Hrs Post Dose	116.6 millimeters of mercury (mmHg)	Standard Deviation 3.7
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 12 Hrs Post Dose	116.5 millimeters of mercury (mmHg)	Standard Deviation 4.9
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, Pre-dose	118.7 millimeters of mercury (mmHg)	Standard Deviation 3.12
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 12 Hrs Post Dose	115.4 millimeters of mercury (mmHg)	Standard Deviation 3.39
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 24 Hrs Post Dose	116.0 millimeters of mercury (mmHg)	Standard Deviation 3.13
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 24 Hrs Post Dose	116.8 millimeters of mercury (mmHg)	Standard Deviation 3.89
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, 2 Hrs Post Dose	71.4 millimeters of mercury (mmHg)	Standard Deviation 5.55
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 24 Hrs Post Dose	116.0 millimeters of mercury (mmHg)	Standard Deviation 3.01
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 4 Hrs Post Dose	75.7 millimeters of mercury (mmHg)	Standard Deviation 4.29
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 6 Hrs Post Dose	71.4 millimeters of mercury (mmHg)	Standard Deviation 3.9
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 12 Hrs Post Dose	73.9 millimeters of mercury (mmHg)	Standard Deviation 4.7
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 24 Hrs Post Dose	75.5 millimeters of mercury (mmHg)	Standard Deviation 2.83
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, Pre-Dose	75.7 millimeters of mercury (mmHg)	Standard Deviation 3.38
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, 2 Hrs Post Dose	71.9 millimeters of mercury (mmHg)	Standard Deviation 4.66
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, 4 Hrs Post Dose	71.5 millimeters of mercury (mmHg)	Standard Deviation 4.89
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, 6 Hrs Post Dose	74.2 millimeters of mercury (mmHg)	Standard Deviation 2.65
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 2 Hrs Post Dose	73.7 millimeters of mercury (mmHg)	Standard Deviation 4.51
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 4 Hrs Post Dose	73.8 millimeters of mercury (mmHg)	Standard Deviation 3.94
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 12 Hrs Post Dose	117.4 millimeters of mercury (mmHg)	Standard Deviation 4.02
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 24 Hrs Post Dose	117.0 millimeters of mercury (mmHg)	Standard Deviation 3.89
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, Pre-dose	116.4 millimeters of mercury (mmHg)	Standard Deviation 3.12
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, Pre-dose	117.9 millimeters of mercury (mmHg)	Standard Deviation 3.73
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 2 Hrs Post Dose	115.7 millimeters of mercury (mmHg)	Standard Deviation 3.67
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 4 Hrs Post Dose	114.8 millimeters of mercury (mmHg)	Standard Deviation 3.51
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 6 Hrs Post Dose	115.2 millimeters of mercury (mmHg)	Standard Deviation 3.69
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, Pre-dose	116.4 millimeters of mercury (mmHg)	Standard Deviation 2.99
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 2 Hrs Post Dose	116.3 millimeters of mercury (mmHg)	Standard Deviation 3.35
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 4 Hrs Post Dose	115.9 millimeters of mercury (mmHg)	Standard Deviation 4.23
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 6 Hrs Post Dose	119.1 millimeters of mercury (mmHg)	Standard Deviation 3.81
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 12 Hrs Post Dose	115.6 millimeters of mercury (mmHg)	Standard Deviation 3.94
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 4, 24 Hrs Post Dose	115.2 millimeters of mercury (mmHg)	Standard Deviation 3
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, Pre-dose	77.1 millimeters of mercury (mmHg)	Standard Deviation 4.32
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2,12 Hrs Post Dose	73.2 millimeters of mercury (mmHg)	Standard Deviation 4.81
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 2, 24 Hrs Post Dose	76.7 millimeters of mercury (mmHg)	Standard Deviation 4.02
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, Pre-Dose	78.9 millimeters of mercury (mmHg)	Standard Deviation 3.48
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, 2 Hrs Post Dose	75.1 millimeters of mercury (mmHg)	Standard Deviation 4.43
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, 4 Hrs Post Dose	73.3 millimeters of mercury (mmHg)	Standard Deviation 3.93
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, 6 Hrs Post Dose	74.4 millimeters of mercury (mmHg)	Standard Deviation 4.78
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3,12 Hrs Post Dose	73.4 millimeters of mercury (mmHg)	Standard Deviation 4.05
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 3, 24 Hrs Post Dose	75.7 millimeters of mercury (mmHg)	Standard Deviation 3.94
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, Pre-Dose	76.0 millimeters of mercury (mmHg)	Standard Deviation 3.68
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 6 Hrs Post Dose	73.8 millimeters of mercury (mmHg)	Standard Deviation 3.34
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 12 Hrs Post Dose	74.7 millimeters of mercury (mmHg)	Standard Deviation 4.31
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 4, 24 Hrs Post Dose	75.6 millimeters of mercury (mmHg)	Standard Deviation 3.12
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, Pre-dose	116.3 millimeters of mercury (mmHg)	Standard Deviation 3.22
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 2 Hrs Post Dose	116.9 millimeters of mercury (mmHg)	Standard Deviation 2.71
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 4 Hrs Post Dose	117.4 millimeters of mercury (mmHg)	Standard Deviation 3.99
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 1, 6 Hrs Post Dose	119.5 millimeters of mercury (mmHg)	Standard Deviation 5.2
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 2 Hrs Post Dose	119.8 millimeters of mercury (mmHg)	Standard Deviation 2.89
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 4 Hrs Post Dose	120.3 millimeters of mercury (mmHg)	Standard Deviation 4.07
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 6 Hrs Post Dose	116.8 millimeters of mercury (mmHg)	Standard Deviation 4.22
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 12 Hrs Post Dose	119.6 millimeters of mercury (mmHg)	Standard Deviation 4.21
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 2, 24 Hrs Post Dose	117.0 millimeters of mercury (mmHg)	Standard Deviation 4.53
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	SBP - Period 3, 12 Hrs Post Dose	115.1 millimeters of mercury (mmHg)	Standard Deviation 3.33
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)	DBP - Period 1, 2 Hrs Post Dose	75.7 millimeters of mercury (mmHg)	Standard Deviation 3.5

Secondary

Absolute Values of Vital Signs: Radial Pulse

Radial pulse was collected in sitting position.

Time frame: At pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period (each period is of 1 day)

Arm	Measure	Group	Value (MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 12 Hrs Post Dose	73.0 beats per minute (bpm)	Standard Deviation 5.21
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 4 Hrs Post Dose	67.9 beats per minute (bpm)	Standard Deviation 3.44
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 4 Hrs Post Dose	73.4 beats per minute (bpm)	Standard Deviation 4.38
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 6 Hrs Post Dose	72.8 beats per minute (bpm)	Standard Deviation 5.05
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 24 Hrs Post Dose	70.9 beats per minute (bpm)	Standard Deviation 5.56
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 12 Hrs Post Dose	70.2 beats per minute (bpm)	Standard Deviation 4.17
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 12 Hrs Post Dose	72.1 beats per minute (bpm)	Standard Deviation 4.8
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 24 Hrs Post Dose	69.2 beats per minute (bpm)	Standard Deviation 3.92
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 4, Pre-dose	75.0 beats per minute (bpm)	Standard Deviation 6.51
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 3, Pre-dose	75.6 beats per minute (bpm)	Standard Deviation 4.02
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 2 Hrs Post Dose	70.6 beats per minute (bpm)	Standard Deviation 3.49
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 2 Hrs Post Dose	69.6 beats per minute (bpm)	Standard Deviation 5.27
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 2 Hrs Post Dose	69.6 beats per minute (bpm)	Standard Deviation 5.04
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 4 Hrs Post Dose	70.8 beats per minute (bpm)	Standard Deviation 5.65
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 24 Hrs Post Dose	72.7 beats per minute (bpm)	Standard Deviation 3.6
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 6 Hrs Post Dose	70.7 beats per minute (bpm)	Standard Deviation 5.22
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 4 Hrs Post Dose	72.2 beats per minute (bpm)	Standard Deviation 2.85
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 2, Pre-dose	72.4 beats per minute (bpm)	Standard Deviation 3.36
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 6 Hrs Post Dose	72.2 beats per minute (bpm)	Standard Deviation 2.98
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 6 Hrs Post Dose	72.8 beats per minute (bpm)	Standard Deviation 3.73
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 12 Hrs Post Dose	70.6 beats per minute (bpm)	Standard Deviation 3.19
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 2 Hrs Post Dose	67.4 beats per minute (bpm)	Standard Deviation 4.48
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 24 Hrs Post Dose	69.9 beats per minute (bpm)	Standard Deviation 4.71
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Radial Pulse	Period 1, Pre-dose	72.9 beats per minute (bpm)	Standard Deviation 6.31
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 24 Hrs Post Dose	71.5 beats per minute (bpm)	Standard Deviation 5.2
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 1, Pre-dose	74.2 beats per minute (bpm)	Standard Deviation 6.62
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 2 Hrs Post Dose	70.4 beats per minute (bpm)	Standard Deviation 3.39
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 4 Hrs Post Dose	72.9 beats per minute (bpm)	Standard Deviation 4.53
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 6 Hrs Post Dose	71.1 beats per minute (bpm)	Standard Deviation 4.37
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 12 Hrs Post Dose	70.7 beats per minute (bpm)	Standard Deviation 3.73
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 6 Hrs Post Dose	71.9 beats per minute (bpm)	Standard Deviation 4.38
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 12 Hrs Post Dose	73.1 beats per minute (bpm)	Standard Deviation 3.52
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 24 Hrs Post Dose	70.6 beats per minute (bpm)	Standard Deviation 4.05
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 4, Pre-dose	75.3 beats per minute (bpm)	Standard Deviation 7.1
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 1, 24 Hrs Post Dose	71.4 beats per minute (bpm)	Standard Deviation 3.68
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 2, Pre-dose	73.9 beats per minute (bpm)	Standard Deviation 5.48
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 2 Hrs Post Dose	68.0 beats per minute (bpm)	Standard Deviation 4.2
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 4 Hrs Post Dose	68.6 beats per minute (bpm)	Standard Deviation 4.2
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 6 Hrs Post Dose	74.2 beats per minute (bpm)	Standard Deviation 4.39
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 12 Hrs Post Dose	71.7 beats per minute (bpm)	Standard Deviation 5.41
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 2, 24 Hrs Post Dose	71.0 beats per minute (bpm)	Standard Deviation 3.26
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 3, Pre-dose	74.7 beats per minute (bpm)	Standard Deviation 6.32
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 2 Hrs Post Dose	71.9 beats per minute (bpm)	Standard Deviation 3.95
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 3, 4 Hrs Post Dose	70.0 beats per minute (bpm)	Standard Deviation 3.66
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 2 Hrs Post Dose	68.8 beats per minute (bpm)	Standard Deviation 3.99
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 4 Hrs Post Dose	71.4 beats per minute (bpm)	Standard Deviation 4.17
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 6 Hrs Post Dose	72.0 beats per minute (bpm)	Standard Deviation 2.52
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Radial Pulse	Period 4, 12 Hrs Post Dose	72.9 beats per minute (bpm)	Standard Deviation 3.1

Secondary

Absolute Values of Vital Signs: Respiratory Rate

Respiratory rate was collected in sitting position.

Time frame: At screening, after check-in and before check-out in each period (each period is of 1 day)

Arm	Measure	Group	Value (MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	Period 1, after Check-in	17.0 breaths per minute (bpm)	Standard Deviation 2.13
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	Period 3, after Check-in	16.9 breaths per minute (bpm)	Standard Deviation 2.24
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	Period 2, after Check-in	17.3 breaths per minute (bpm)	Standard Deviation 2.72
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	Period 3, before Check-out	17.0 breaths per minute (bpm)	Standard Deviation 1.95
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	Period 1, before Check-out	16.5 breaths per minute (bpm)	Standard Deviation 2.69
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	Period 4, after Check-in	18.6 breaths per minute (bpm)	Standard Deviation 2.2
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	Period 2, before Check-out	17.6 breaths per minute (bpm)	Standard Deviation 2.41
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	Period 4, before Check-out	17.9 breaths per minute (bpm)	Standard Deviation 2.28
Albendazole IP 400 mg/400mg - Test 1 (T1)	Absolute Values of Vital Signs: Respiratory Rate	At Screening	15.5 breaths per minute (bpm)	Standard Deviation 2.08
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	Period 4, before Check-out	17.7 breaths per minute (bpm)	Standard Deviation 2.26
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	At Screening	15.8 breaths per minute (bpm)	Standard Deviation 2.21
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	Period 1, after Check-in	16.4 breaths per minute (bpm)	Standard Deviation 1.82
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	Period 1, before Check-out	16.5 breaths per minute (bpm)	Standard Deviation 2.33
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	Period 2, after Check-in	16.8 breaths per minute (bpm)	Standard Deviation 2.34
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	Period 2, before Check-out	16.8 breaths per minute (bpm)	Standard Deviation 2.64
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	Period 3, after Check-in	17.6 breaths per minute (bpm)	Standard Deviation 2.5
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	Period 3, before Check-out	16.3 breaths per minute (bpm)	Standard Deviation 2.06
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Absolute Values of Vital Signs: Respiratory Rate	Period 4, after Check-in	18.3 breaths per minute (bpm)	Standard Deviation 2.67

Secondary

Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide

Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide	6129.744 ng*h/mL	Geometric Coefficient of Variation 74.2
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide	6023.449 ng*h/mL	Geometric Coefficient of Variation 68.9
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide	6046.054 ng*h/mL	Geometric Coefficient of Variation 73.2
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide	6572.338 ng*h/mL	Geometric Coefficient of Variation 67.8

Secondary

Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide

Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Albendazole	189.347 ng*h/mL	Geometric Coefficient of Variation 128.6
Albendazole IP 400 mg/400mg - Test 1 (T1)	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	7372.856 ng*h/mL	Geometric Coefficient of Variation 80.1
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	7189.644 ng*h/mL	Geometric Coefficient of Variation 73.4
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Albendazole	174.979 ng*h/mL	Geometric Coefficient of Variation 119
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Albendazole	169.433 ng*h/mL	Geometric Coefficient of Variation 127.1
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	7204.107 ng*h/mL	Geometric Coefficient of Variation 81.2
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Albendazole	192.388 ng*h/mL	Geometric Coefficient of Variation 116.1
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	7816.474 ng*h/mL	Geometric Coefficient of Variation 74.5

Secondary

Change From Baseline in Vital Signs: Blood Pressure

Diastolic blood pressure (DBP) and systolic blood pressure (SBP) were collected in sitting position.

Time frame: Pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period

Arm	Measure	Group	Value (MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 12 Hrs Post Dose	-2.2 millimeters of mercury (mmHg)	Standard Deviation 5.55
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 6 Hrs Post Dose	-3.7 millimeters of mercury (mmHg)	Standard Deviation 5.18
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 2 Hrs Post Dose	-1.3 millimeters of mercury (mmHg)	Standard Deviation 5.66
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 4 Hrs Post Dose	-1.5 millimeters of mercury (mmHg)	Standard Deviation 6.44
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 6 Hrs Post Dose	-2.7 millimeters of mercury (mmHg)	Standard Deviation 6.86
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 12 Hrs Post Dose	-2.2 millimeters of mercury (mmHg)	Standard Deviation 7.29
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 24 Hrs Post Dose	0.1 millimeters of mercury (mmHg)	Standard Deviation 5.85
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 2 Hrs Post Dose	-1.5 millimeters of mercury (mmHg)	Standard Deviation 7.15
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 4 Hrs Post Dose	-2.6 millimeters of mercury (mmHg)	Standard Deviation 5.35
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 6 Hrs Post Dose	1.5 millimeters of mercury (mmHg)	Standard Deviation 3.53
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 24 Hrs Post Dose	3.3 millimeters of mercury (mmHg)	Standard Deviation 5.13
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 2 Hrs Post Dose	-5.3 millimeters of mercury (mmHg)	Standard Deviation 6.77
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 4 Hrs Post Dose	-2.6 millimeters of mercury (mmHg)	Standard Deviation 5.12
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 6 Hrs Post Dose	-3.8 millimeters of mercury (mmHg)	Standard Deviation 6.82
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 12 Hrs Post Dose	-3.9 millimeters of mercury (mmHg)	Standard Deviation 5.03
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 24 Hrs Post Dose	-2.9 millimeters of mercury (mmHg)	Standard Deviation 3.83
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 2 Hrs Post Dose	-3.8 millimeters of mercury (mmHg)	Standard Deviation 5.69
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 4 Hrs Post Dose	-2.3 millimeters of mercury (mmHg)	Standard Deviation 4.25
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 6 Hrs Post Dose	-3.1 millimeters of mercury (mmHg)	Standard Deviation 4.35
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 12 Hrs Post Dose	-2.0 millimeters of mercury (mmHg)	Standard Deviation 4.32
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 24 Hrs Post Dose	0.6 millimeters of mercury (mmHg)	Standard Deviation 4.52
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 2 Hrs Post Dose	0.1 millimeters of mercury (mmHg)	Standard Deviation 5.09
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 4 Hrs Post Dose	0.2 millimeters of mercury (mmHg)	Standard Deviation 5.5
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 6 Hrs Post Dose	1.1 millimeters of mercury (mmHg)	Standard Deviation 5.3
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 12 Hrs Post Dose	0.3 millimeters of mercury (mmHg)	Standard Deviation 5.69
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 24 Hrs Post Dose	0.6 millimeters of mercury (mmHg)	Standard Deviation 5.61
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 2 Hrs Post Dose	6.4 millimeters of mercury (mmHg)	Standard Deviation 7.6
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 4 Hrs Post Dose	5.5 millimeters of mercury (mmHg)	Standard Deviation 6.09
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 6 Hrs Post Dose	3.6 millimeters of mercury (mmHg)	Standard Deviation 5.9
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 12 Hrs Post Dose	4.8 millimeters of mercury (mmHg)	Standard Deviation 6.08
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 24 Hrs Post Dose	2.8 millimeters of mercury (mmHg)	Standard Deviation 5.93
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 2 Hrs Post Dose	-4.5 millimeters of mercury (mmHg)	Standard Deviation 4.95
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 4 Hrs Post Dose	-2.8 millimeters of mercury (mmHg)	Standard Deviation 5.42
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 12 Hrs Post Dose	-3.3 millimeters of mercury (mmHg)	Standard Deviation 4.27
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 24 Hrs Post Dose	-1.9 millimeters of mercury (mmHg)	Standard Deviation 4.17
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 2 Hrs Post Dose	-0.4 millimeters of mercury (mmHg)	Standard Deviation 4.18
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 4 Hrs Post Dose	-0.4 millimeters of mercury (mmHg)	Standard Deviation 5.3
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 6 Hrs Post Dose	1.3 millimeters of mercury (mmHg)	Standard Deviation 4.34
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 12 Hrs Post Dose	-0.7 millimeters of mercury (mmHg)	Standard Deviation 4.99
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 24 Hrs Post Dose	-0.9 millimeters of mercury (mmHg)	Standard Deviation 4.27
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 12 Hrs Post Dose	-0.8 millimeters of mercury (mmHg)	Standard Deviation 5.67
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 12 Hrs Post Dose	-1.3 millimeters of mercury (mmHg)	Standard Deviation 5.62
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 6 Hrs Post Dose	-2.7 millimeters of mercury (mmHg)	Standard Deviation 4.84
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 12 Hrs Post Dose	3.2 millimeters of mercury (mmHg)	Standard Deviation 4.64
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 24 Hrs Post Dose	-0.4 millimeters of mercury (mmHg)	Standard Deviation 4.38
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 2 Hrs Post Dose	-1.4 millimeters of mercury (mmHg)	Standard Deviation 5.71
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 4 Hrs Post Dose	-1.4 millimeters of mercury (mmHg)	Standard Deviation 5.73
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 6 Hrs Post Dose	-5.7 millimeters of mercury (mmHg)	Standard Deviation 6.14
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 24 Hrs Post Dose	0.6 millimeters of mercury (mmHg)	Standard Deviation 6.1
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 12 Hrs Post Dose	-3.2 millimeters of mercury (mmHg)	Standard Deviation 6.55
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 2 Hrs Post Dose	0.6 millimeters of mercury (mmHg)	Standard Deviation 4.1
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 1, 24 Hrs Post Dose	-1.5 millimeters of mercury (mmHg)	Standard Deviation 4.6
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 6 Hrs Post Dose	2.7 millimeters of mercury (mmHg)	Standard Deviation 3.66
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 4 Hrs Post Dose	1.1 millimeters of mercury (mmHg)	Standard Deviation 4.98
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 2 Hrs Post Dose	-3.8 millimeters of mercury (mmHg)	Standard Deviation 5.57
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 2 Hrs Post Dose	-2.2 millimeters of mercury (mmHg)	Standard Deviation 4.58
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 4 Hrs Post Dose	-4.2 millimeters of mercury (mmHg)	Standard Deviation 6.23
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 6 Hrs Post Dose	3.3 millimeters of mercury (mmHg)	Standard Deviation 6.21
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 6 Hrs Post Dose	-1.5 millimeters of mercury (mmHg)	Standard Deviation 4.06
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 2 Hrs Post Dose	-0.1 millimeters of mercury (mmHg)	Standard Deviation 3.82
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 12 Hrs Post Dose	-2.5 millimeters of mercury (mmHg)	Standard Deviation 5.7
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 12 Hrs Post Dose	1.1 millimeters of mercury (mmHg)	Standard Deviation 4.63
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 2, 24 Hrs Post Dose	1.0 millimeters of mercury (mmHg)	Standard Deviation 5.93
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 4 Hrs Post Dose	-3.1 millimeters of mercury (mmHg)	Standard Deviation 4.98
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 1, 24 Hrs Post Dose	0.7 millimeters of mercury (mmHg)	Standard Deviation 5.72
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 2 Hrs Post Dose	-3.8 millimeters of mercury (mmHg)	Standard Deviation 5.09
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 24 Hrs Post Dose	-1.2 millimeters of mercury (mmHg)	Standard Deviation 3.66
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 4 Hrs Post Dose	-5.7 millimeters of mercury (mmHg)	Standard Deviation 4.37
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 6 Hrs Post Dose	-4.6 millimeters of mercury (mmHg)	Standard Deviation 6.18
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 12 Hrs Post Dose	-2.8 millimeters of mercury (mmHg)	Standard Deviation 5.32
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 12 Hrs Post Dose	-5.6 millimeters of mercury (mmHg)	Standard Deviation 5.15
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 2 Hrs Post Dose	3.4 millimeters of mercury (mmHg)	Standard Deviation 3.39
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 3, 24 Hrs Post Dose	-3.3 millimeters of mercury (mmHg)	Standard Deviation 4.89
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 4, 4 Hrs Post Dose	-0.5 millimeters of mercury (mmHg)	Standard Deviation 4.67
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, Pre-dose	0.0 millimeters of mercury (mmHg)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 4 Hrs Post Dose	3.9 millimeters of mercury (mmHg)	Standard Deviation 5.35
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 2 Hrs Post Dose	-2.3 millimeters of mercury (mmHg)	Standard Deviation 4.6
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 3, 24 Hrs Post Dose	-1.9 millimeters of mercury (mmHg)	Standard Deviation 4.13
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 4 Hrs Post Dose	-2.2 millimeters of mercury (mmHg)	Standard Deviation 5.24
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	SBP - Period 2, 6 Hrs Post Dose	0.4 millimeters of mercury (mmHg)	Standard Deviation 5.12
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Blood Pressure	DBP - Period 4, 6 Hrs Post Dose	-2.2 millimeters of mercury (mmHg)	Standard Deviation 4.34

Secondary

Change From Baseline in Vital Signs: Radial Pulse

Radial pulse was collected in sitting position.

Time frame: pre-dose (within 60 minutes before the dosing) and at 2, 4, 6, 12 and 24 hours post-dose in each period

Arm	Measure	Group	Value (MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, Pre-dose	0.0 beats per minute (bpm)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 2 Hrs Post Dose	-2.2 beats per minute (bpm)	Standard Deviation 6.86
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 4 Hrs Post Dose	0.6 beats per minute (bpm)	Standard Deviation 7.57
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 6 Hrs Post Dose	-0.1 beats per minute (bpm)	Standard Deviation 7.87
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 12 Hrs Post Dose	-0.7 beats per minute (bpm)	Standard Deviation 8.85
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 24 Hrs Post Dose	-0.1 beats per minute (bpm)	Standard Deviation 7.64
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, Pre-dose	0.0 beats per minute (bpm)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 2 Hrs Post Dose	-5.0 beats per minute (bpm)	Standard Deviation 5.08
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 4 Hrs Post Dose	-4.5 beats per minute (bpm)	Standard Deviation 5.05
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 6 Hrs Post Dose	0.5 beats per minute (bpm)	Standard Deviation 5.95
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 12 Hrs Post Dose	-2.2 beats per minute (bpm)	Standard Deviation 5.71
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 24 Hrs Post Dose	-3.2 beats per minute (bpm)	Standard Deviation 5.58
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, Pre-dose	0.0 beats per minute (bpm)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 2 Hrs Post Dose	-6.0 beats per minute (bpm)	Standard Deviation 6.41
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 4 Hrs Post Dose	-4.8 beats per minute (bpm)	Standard Deviation 5.47
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 6 Hrs Post Dose	-4.9 beats per minute (bpm)	Standard Deviation 6.32
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 12 Hrs Post Dose3	-2.6 beats per minute (bpm)	Standard Deviation 7.82
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 24 Hrs Post Dose	-4.7 beats per minute (bpm)	Standard Deviation 6.73
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, Pre-dose	0.0 beats per minute (bpm)	Standard Deviation 0
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 2 Hrs Post Dose	-5.4 beats per minute (bpm)	Standard Deviation 8.94
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 4 Hrs Post Dose	-2.8 beats per minute (bpm)	Standard Deviation 8.16
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 6 Hrs Post Dose	-2.8 beats per minute (bpm)	Standard Deviation 7.09
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 12 Hrs Post Dose	-4.4 beats per minute (bpm)	Standard Deviation 7.27
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 24 Hrs Post Dose	-5.1 beats per minute (bpm)	Standard Deviation 7.73
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 12 Hrs Post Dose	-2.3 beats per minute (bpm)	Standard Deviation 7.3
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, Pre-dose	0.0 beats per minute (bpm)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, Pre-dose	0.0 beats per minute (bpm)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 2 Hrs Post Dose	-3.8 beats per minute (bpm)	Standard Deviation 7.79
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, Pre-dose	0.0 beats per minute (bpm)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 4 Hrs Post Dose	-1.3 beats per minute (bpm)	Standard Deviation 9.23
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 2 Hrs Post Dose	-2.8 beats per minute (bpm)	Standard Deviation 6.7
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 6 Hrs Post Dose	-3.0 beats per minute (bpm)	Standard Deviation 7.71
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 6 Hrs Post Dose	-3.3 beats per minute (bpm)	Standard Deviation 6.53
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 12 Hrs Post Dose	-3.4 beats per minute (bpm)	Standard Deviation 7.89
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 4 Hrs Post Dose	-4.7 beats per minute (bpm)	Standard Deviation 7.09
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 1, 24 Hrs Post Dose	-2.7 beats per minute (bpm)	Standard Deviation 7.96
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 2 Hrs Post Dose	-6.5 beats per minute (bpm)	Standard Deviation 8.23
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, Pre-dose	0.0 beats per minute (bpm)	Standard Deviation 0
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 6 Hrs Post Dose	-2.8 beats per minute (bpm)	Standard Deviation 7.72
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 2 Hrs Post Dose	-5.9 beats per minute (bpm)	Standard Deviation 5.4
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 24 Hrs Post Dose	-3.8 beats per minute (bpm)	Standard Deviation 8.34
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 4 Hrs Post Dose	-5.4 beats per minute (bpm)	Standard Deviation 6.23
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 12 Hrs Post Dose3	-1.6 beats per minute (bpm)	Standard Deviation 7.07
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 6 Hrs Post Dose	0.3 beats per minute (bpm)	Standard Deviation 6.98
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 4, 4 Hrs Post Dose	-3.9 beats per minute (bpm)	Standard Deviation 8.44
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 12 Hrs Post Dose	-2.2 beats per minute (bpm)	Standard Deviation 8.41
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 3, 24 Hrs Post Dose	-4.1 beats per minute (bpm)	Standard Deviation 7.71
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Radial Pulse	Period 2, 24 Hrs Post Dose	-2.9 beats per minute (bpm)	Standard Deviation 6.47

Secondary

Change From Baseline in Vital Signs: Respiratory Rate

Respiratory rate was collected in sitting position.

Time frame: After Check-in (Baseline) and before Check-out for each period (each period is of 1 day)

Arm	Measure	Group	Value (MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Respiratory Rate	Period 1	-0.6 breaths per minute (bpm)	Standard Deviation 3.72
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Respiratory Rate	Period 2	0.6 breaths per minute (bpm)	Standard Deviation 3.56
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Respiratory Rate	Period 3	0.2 breaths per minute (bpm)	Standard Deviation 2.53
Albendazole IP 400 mg/400mg - Test 1 (T1)	Change From Baseline in Vital Signs: Respiratory Rate	Period 4	0.9 breaths per minute (bpm)	Standard Deviation 3.41
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Respiratory Rate	Period 4	1.3 breaths per minute (bpm)	Standard Deviation 3.07
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Respiratory Rate	Period 1	0.2 breaths per minute (bpm)	Standard Deviation 2.26
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Respiratory Rate	Period 3	-0.0 breaths per minute (bpm)	Standard Deviation 3.27
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Change From Baseline in Vital Signs: Respiratory Rate	Period 2	0.4 breaths per minute (bpm)	Standard Deviation 3.91

Secondary

Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide

Blood samples were collected for PK analysis of Albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide	638.051 ng/mL	Geometric Coefficient of Variation 63.3
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide	644.730 ng/mL	Geometric Coefficient of Variation 59.4
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide	643.276 ng/mL	Geometric Coefficient of Variation 62.6
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide	710.382 ng/mL	Geometric Coefficient of Variation 53.8

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

Time frame: Up to 22 days

Population: Safety Population included all randomized participants who received at least 1 dose of study medication. Each participant was counted once throughout the study for this analysis.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Albendazole IP 400 mg/400mg - Test 1 (T1)	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	7 Participants
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	6 Participants

Secondary

Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide

Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Albendazole	3.304 Percentage	Geometric Coefficient of Variation 111.2
Albendazole IP 400 mg/400mg - Test 1 (T1)	Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	14.513 Percentage	Geometric Coefficient of Variation 47.9
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	13.726 Percentage	Geometric Coefficient of Variation 45.7
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Albendazole	3.241 Percentage	Geometric Coefficient of Variation 99
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Albendazole	3.763 Percentage	Geometric Coefficient of Variation 112.6
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	13.795 Percentage	Geometric Coefficient of Variation 45.1
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Albendazole	3.275 Percentage	Geometric Coefficient of Variation 90.6
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	13.243 Percentage	Geometric Coefficient of Variation 50.8

Secondary

Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide

Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Albendazole	5.22 hour (h)	Geometric Coefficient of Variation 55.1
Albendazole IP 400 mg/400mg - Test 1 (T1)	Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	8.47 hour (h)	Geometric Coefficient of Variation 34.8
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	8.20 hour (h)	Geometric Coefficient of Variation 28.4
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Albendazole	5.53 hour (h)	Geometric Coefficient of Variation 74.9
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Albendazole	5.11 hour (h)	Geometric Coefficient of Variation 60
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	8.21 hour (h)	Geometric Coefficient of Variation 28.2
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Albendazole	5.62 hour (h)	Geometric Coefficient of Variation 56
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	8.07 hour (h)	Geometric Coefficient of Variation 32.8

Secondary

Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide

Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	0.082 1/h	Geometric Coefficient of Variation 29.3
Albendazole IP 400 mg/400mg - Test 1 (T1)	Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Albendazole	0.133 1/h	Geometric Coefficient of Variation 57.6
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Albendazole	0.125 1/h	Geometric Coefficient of Variation 61.8
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	0.085 1/h	Geometric Coefficient of Variation 40.7
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	0.084 1/h	Geometric Coefficient of Variation 33
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Albendazole	0.136 1/h	Geometric Coefficient of Variation 60.8
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	0.086 1/h	Geometric Coefficient of Variation 38.9
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide	Albendazole	0.123 1/h	Geometric Coefficient of Variation 43.8

Secondary

Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide

Blood samples were collected for PK analysis of Albendazole and albendazole sulfoxide. PK parameter was determined using standard non-compartmental methods.

Time frame: Pre-dose, 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.50, 5, 6, 8, 10, 12, 14, 18 and 24 hours

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Albendazole IP 400 mg/400mg - Test 1 (T1)	Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Albendazole	3.31 hour (h)	Geometric Coefficient of Variation 33.4
Albendazole IP 400 mg/400mg - Test 1 (T1)	Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	4.64 hour (h)	Geometric Coefficient of Variation 16.4
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	4.64 hour (h)	Geometric Coefficient of Variation 21.7
Albendazole IP 400 mg/400 mg - Test 2 (T2)	Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Albendazole	3.41 hour (h)	Geometric Coefficient of Variation 30.4
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Albendazole	3.39 hour (h)	Geometric Coefficient of Variation 32.9
Albendazole 400 mg/IP 400 mg - Reference 1 (R1)	Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	4.62 hour (h)	Geometric Coefficient of Variation 19.4
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Albendazole	3.52 hour (h)	Geometric Coefficient of Variation 30.6
Albendazole 400 mg/IP 400 mg - Reference 2 (R2)	Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide	Albendazole sulfoxide	4.63 hour (h)	Geometric Coefficient of Variation 20

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] for Albendazole

Maximum Plasma Concentration (Cmax) of Albendazole

Absolute Values of Vital Signs: Blood Pressure (Diastolic and Systolic)

Absolute Values of Vital Signs: Radial Pulse

Absolute Values of Vital Signs: Respiratory Rate

Area Under the Plasma Concentration Curve From Time 0 to the Last Measured [AUC(0-t)] of Albendazole Sulfoxide

Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [AUC0-inf] of Albendazole and Albendazole Sulfoxide

Change From Baseline in Vital Signs: Blood Pressure

Change From Baseline in Vital Signs: Radial Pulse

Change From Baseline in Vital Signs: Respiratory Rate

Maximum Plasma Concentration (Cmax) of Albendazole Sulfoxide

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Observed Percentage of Extrapolated Area Under Concentration (AUC_% Extrap_obs) for Albendazole and Albendazole Sulfoxide

Plasma Concentration Half-life (t1/2) of Albendazole and Albendazole Sulfoxide

Terminal Elimination Rate Constant (Lambda-z (λz)) of Albendazole and Albendazole Sulfoxide

Time Until Cmax is Reached (Tmax) for Albendazole and Albendazole Sulfoxide