Heart Failure, Hypertension
Conditions
Brief summary
Prazosin hydrochloride (HCl) is an oral anti-hypertensive indicated for the treatment of primary and secondary hypertension and heart failure. Pfizer Inc. is the marketing authorization holder for prazosin HCl oral capsules and intended to transfer drug product manufacturing operations from Pfizer, Barceloneta Puerto Rico to Pfizer Pharmaceutical, Ascoli, Italy. To support the manufacturer site transfer and process changes, this bioequivalence (BE) study is being conducted. This study will be a 2 Cohort, open-label, randomized, single dose study in healthy adult male and/or female participants. Cohort 1 will be crossover with 3 treatments, 3 periods, 6 sequences. Cohort 2 will be crossover with 2 treatments, 2 periods, 2 sequences. Primary objective of this study is demonstrate bioequivalence between prazosin HCl 1, 2 and 5 mg capsules manufactured at Ascoli versus prazosin HCl 2 and 5 mg capsules manufactured at Barceloneta under fasting conditions in healthy adult participants. Approximately 36 participants will be enrolled in each Cohort 1 and Cohort 2. Pharmacokinetic and statistical analysis will be performed for prazosin. Data from 2 Cohorts will be analyzed separately. The PK parameters area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast), and from time zero extrapolated to infinite time (AUCinf), maximum plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), and terminal phase elimination half-life (t½) will be summarized descriptively by analyte and treatment. For primary objective, bioequivalence of the Test treatment relative to Reference treatment will be concluded if the 90% confidence intervals (CI) for the ratio of adjusted geometric means of Test treatments relative to Reference treatment for AUCinf (if data permit), AUClast and Cmax, fall wholly within (80%, 125%).
Interventions
DRUGPrazosin HCl 2mg
Prazosin HCL 1 X 2 mg capsule.
DRUGPrazosin HCl 1 mg
Prazosin HCl 2 X 1 mg capsule.
DRUGPrazosin HCl 5 mg
Prazosin HCL 1 X 5 mg capsule.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Document (ICD). * Male and female participants who are overtly healthy as determined by medical evaluation including medical history, full physical examination, vital signs, 12-lead electrocardiogram (ECG), and/or clinical laboratory tests. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations , and other study procedures. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. * Any condition possibly affecting drug absorption (eg, gastrectomy). * History of Human Immunodeficiency Virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed. * Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. * A positive urine drug test. * Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. * Baseline standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. * Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary: * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.5 × upper limit of normal (ULN); * Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN. * History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. * Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day. For chewing tobacco, one chew is equivalent to approximately 2 to 3 cigarettes, so participants would be limited to 2 or less chews per day. * History of sensitivity to prazosin hydrochloride or any of the components in the formulation of the study products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period |
| Maximum Observed Plasma Concentration (Cmax) of Prazosin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period | — |
| Plasma Decay Half-Life (t1/2) of Prazosin | 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period | Plasma terminal elimination half-life of Prazosin was measured. |
| Number of Participants With Adverse Events (AEs) According to Seriousness | Time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2. | Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant. |
Countries
United States
Participant flow
Pre-assignment details
A total of 72 participants were enrolled in the study and both cohorts (2 cohorts in total) enrolled 36 particpants.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Male Male participants enrolled to the cohort 1 of the study. | 24 |
| Cohort 1: Female Female participants enrolled to the cohort 1 of the study. | 12 |
| Cohort 2: Male Male participants enrolled to the cohort 2 of the study. | 20 |
| Cohort 2: Female Female participants enrolled to the cohort 2 of the study. | 16 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Follow-Up | Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Follow-Up | Lost to Follow-up | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Follow-Up | Withdrawal by Subject | 0 | 1 | 0 | 1 | 0 | 1 | 2 | 3 |
| Open Label Treatment | Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Open Label Treatment | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Open Label Treatment | Withdrawal by Subject | 0 | 1 | 0 | 1 | 0 | 1 | 2 | 3 |
Baseline characteristics
| Characteristic | Total | Cohort 1: Male | Cohort 1: Female | Cohort 2: Male | Cohort 2: Female |
|---|---|---|---|---|---|
| Age, Customized 18-44 years | 51 Participants | 16 Participants | 7 Participants | 18 Participants | 10 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 45-64 years | 21 Participants | 8 Participants | 5 Participants | 2 Participants | 6 Participants |
| Age, Customized ≥65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 11 Participants | 4 Participants | 8 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 13 Participants | 8 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 8 Participants | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 16 Participants | 8 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Female | 28 Participants | 0 Participants | 12 Participants | 0 Participants | 16 Participants |
| Sex: Female, Male Male | 44 Participants | 24 Participants | 0 Participants | 20 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 34 | 0 / 33 | 0 / 33 | 0 / 33 | 0 / 34 |
| other Total, other adverse events | 8 / 34 | 4 / 33 | 5 / 33 | 16 / 33 | 18 / 34 |
| serious Total, serious adverse events | 1 / 34 | 0 / 33 | 0 / 33 | 0 / 33 | 0 / 34 |
Outcome results
Primary
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Population: The AUClast analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Prazosin HCL 1x2 mg (Barceloneta) | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin | 85.77 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 34 |
| Prazosin HCL 1x2 mg (Ascoli) | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin | 88.37 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 31 |
| Prazosin HCL 2x1 mg (Ascoli) | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin | 92.39 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 34 |
| Prazosin HCL 1x5 mg (Barceloneta) | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin | 192.3 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 147 |
| Prazosin HCL 1x5 mg (Ascoli) | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Prazosin | 252.2 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 37 |
Comparison: Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)90% CI: [96.14, 108.43]Mixed Models Analysis
Comparison: Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)90% CI: [98.68, 111.44]Mixed Models Analysis
Comparison: Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)90% CI: [99.58, 109.55]Mixed Models Analysis
Primary
Maximum Observed Plasma Concentration (Cmax) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Population: The Cmax analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Prazosin HCL 1x2 mg (Barceloneta) | Maximum Observed Plasma Concentration (Cmax) of Prazosin | 14.82 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 49 |
| Prazosin HCL 1x2 mg (Ascoli) | Maximum Observed Plasma Concentration (Cmax) of Prazosin | 17.04 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 36 |
| Prazosin HCL 2x1 mg (Ascoli) | Maximum Observed Plasma Concentration (Cmax) of Prazosin | 19.20 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 37 |
| Prazosin HCL 1x5 mg (Barceloneta) | Maximum Observed Plasma Concentration (Cmax) of Prazosin | 30.91 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 143 |
| Prazosin HCL 1x5 mg (Ascoli) | Maximum Observed Plasma Concentration (Cmax) of Prazosin | 38.69 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 132 |
Comparison: Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)90% CI: [102.79, 126.34]Mixed Models Analysis
Comparison: Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)90% CI: [114.32, 140.7]Mixed Models Analysis
Comparison: Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)90% CI: [106.46, 130.94]Mixed Models Analysis
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Population: The AUCinf analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Prazosin HCL 1x2 mg (Barceloneta) | Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin | 89.10 ng*hr/mL | Geometric Coefficient of Variation 33 |
| Prazosin HCL 1x2 mg (Ascoli) | Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin | 90.28 ng*hr/mL | Geometric Coefficient of Variation 31 |
| Prazosin HCL 2x1 mg (Ascoli) | Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin | 93.01 ng*hr/mL | Geometric Coefficient of Variation 31 |
| Prazosin HCL 1x5 mg (Barceloneta) | Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin | 236.7 ng*hr/mL | Geometric Coefficient of Variation 37 |
| Prazosin HCL 1x5 mg (Ascoli) | Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prazosin | 259.0 ng*hr/mL | Geometric Coefficient of Variation 37 |
Comparison: Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)90% CI: [94.92, 107.27]Mixed Models Analysis
Comparison: Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)90% CI: [95.97, 108.57]Mixed Models Analysis
Comparison: Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)90% CI: [99.09, 109.23]Mixed Models Analysis
Secondary
Number of Participants With Adverse Events (AEs) According to Seriousness
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Time frame for safety monitoring was from screening to Follow-Up Completion (Day 35 after the last dose administration of the last period), and the actual time frame might vary according to the number of doses received and the length of washing period of each dose for each participant.
Time frame: Time frame varied from 20 days to 94 days for cohort 1, and 8 days to 73 days for cohort 2.
Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prazosin HCL 1x2 mg (Barceloneta) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (all-causality) | 1 Participants |
| Prazosin HCL 1x2 mg (Barceloneta) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (treatment-related) | 9 Participants |
| Prazosin HCL 1x2 mg (Barceloneta) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (treatment-related) | 0 Participants |
| Prazosin HCL 1x2 mg (Barceloneta) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (all-causality) | 10 Participants |
| Prazosin HCL 1x2 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (treatment-related) | 0 Participants |
| Prazosin HCL 1x2 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (all-causality) | 5 Participants |
| Prazosin HCL 1x2 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (all-causality) | 0 Participants |
| Prazosin HCL 1x2 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (treatment-related) | 4 Participants |
| Prazosin HCL 2x1 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (all-causality) | 6 Participants |
| Prazosin HCL 2x1 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (treatment-related) | 5 Participants |
| Prazosin HCL 2x1 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (all-causality) | 0 Participants |
| Prazosin HCL 2x1 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (treatment-related) | 0 Participants |
| Prazosin HCL 1x5 mg (Barceloneta) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (all-causality) | 17 Participants |
| Prazosin HCL 1x5 mg (Barceloneta) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (treatment-related) | 0 Participants |
| Prazosin HCL 1x5 mg (Barceloneta) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (treatment-related) | 16 Participants |
| Prazosin HCL 1x5 mg (Barceloneta) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (all-causality) | 0 Participants |
| Prazosin HCL 1x5 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (treatment-related) | 18 Participants |
| Prazosin HCL 1x5 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (all-causality) | 0 Participants |
| Prazosin HCL 1x5 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with non-serious AEs (all-causality) | 18 Participants |
| Prazosin HCL 1x5 mg (Ascoli) | Number of Participants With Adverse Events (AEs) According to Seriousness | Participants with SAEs (treatment-related) | 0 Participants |
Secondary
Plasma Decay Half-Life (t1/2) of Prazosin
Plasma terminal elimination half-life of Prazosin was measured.
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Population: The t1/2 analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prazosin HCL 1x2 mg (Barceloneta) | Plasma Decay Half-Life (t1/2) of Prazosin | 5.330 hr | Standard Deviation 1.2494 |
| Prazosin HCL 1x2 mg (Ascoli) | Plasma Decay Half-Life (t1/2) of Prazosin | 5.236 hr | Standard Deviation 1.0565 |
| Prazosin HCL 2x1 mg (Ascoli) | Plasma Decay Half-Life (t1/2) of Prazosin | 5.022 hr | Standard Deviation 1.1691 |
| Prazosin HCL 1x5 mg (Barceloneta) | Plasma Decay Half-Life (t1/2) of Prazosin | 4.676 hr | Standard Deviation 1.1422 |
| Prazosin HCL 1x5 mg (Ascoli) | Plasma Decay Half-Life (t1/2) of Prazosin | 4.775 hr | Standard Deviation 1.1594 |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of each period
Population: The Tmax analysis population is defined as all participants randomized and treated who had at least 1 of the PK parameters of secondary interest in at least 1 treatment period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prazosin HCL 1x2 mg (Barceloneta) | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin | 2.00 hr |
| Prazosin HCL 1x2 mg (Ascoli) | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin | 2.00 hr |
| Prazosin HCL 2x1 mg (Ascoli) | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin | 1.50 hr |
| Prazosin HCL 1x5 mg (Barceloneta) | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin | 2.50 hr |
| Prazosin HCL 1x5 mg (Ascoli) | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Prazosin | 2.00 hr |