Healthy
Conditions
Brief summary
The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed conditions.
Interventions
DRUGTamsulosin
Test 0.4 mg Capsule
Sponsors
Teva Pharmaceuticals USA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy, non-smoking male subjects, 18 years of age or older. * BMI greater than or equal to 19 and less than or equal to 30. * Negative for: * HIV. * Hepatitis B surface antigen and Hepatitis C antibody. * Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). * Urine cotinine test * No significant diseases or clinically significant findings in a physical examination. * No clinically significant abnormal laboratory values. * No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG). * Systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 60-90 mmgHg. * Be informed of the nature of the study and given written consent prior to receiving any study procedure.
Exclusion criteria
* Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration. * Known or suspected carcinoma. * Known history or presence of: * Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity. * Alcoholism within the last 12 months. * Drug dependence and/or substance abuse. * Use of tobacco or nicotine-containing products within the last 6 months. * Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing. * Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing. * On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet). * Participated in another clinical trial or received and investigational product within 30 days prior to drug administration. * Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation. * Difficulty fasting or consuming the standard meals. * Do not tolerate venipuncture. * Unable to read or sign the ICF.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples drawn over 60 hour period | Bioequivalence based on Cmax |
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples drawn over 60 hour period | Bioequivalence based on AUC0-t |
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples drawn over 60 hour period | Bioequivalence based on AUC0-inf |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tamsulosin 0.4 mg Capsule | 16 |
| Flomax® 0.4 mg Capsule | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Tamsulosin | Flomax® | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black | 1 participants | 4 participants | 5 participants |
| Race/Ethnicity, Customized Caucasian | 14 participants | 12 participants | 26 participants |
| Region of Enrollment Canada | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf
Time frame: Blood samples drawn over 60 hour period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | 143.2749 ng*h/mL | Standard Deviation 29 |
| Flomax® | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | 157.9455 ng*h/mL | Standard Deviation 30 |
90% CI: [86.59, 94.89]
Primary
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t
Time frame: Blood samples drawn over 60 hour period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | 137.0248 ng*h/mL | Standard Deviation 27 |
| Flomax® | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | 148.9023 ng*h/mL | Standard Deviation 28 |
90% CI: [87.72, 96.1]
Primary
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Cmax
Time frame: Blood samples drawn over 60 hour period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | 8.8694 ng/mL | Standard Deviation 28 |
| Flomax® | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | 9.0150 ng/mL | Standard Deviation 26 |
90% CI: [91, 105.32]