Healthy
Conditions
Keywords
Bioequivalence, Healthy Subjects
Brief summary
The objective of this study is to compare the relative bioavailability of finasteride 5 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg tablets (Merck) in healthy, adult, non-smoking, male subjects under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Interventions
1 x 5 mg, single dose fasting
DRUGPROSCAR®
1 x 5 mg, single dose fasting
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
* All subjects selected for this study will be male non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history. Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements. Clinical laboratory measurements will include the following: * Hematology: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count (with differential). * Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase. * Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells. * HIV Screen: pre-study * Hepatitis B, C Screen: pre-study * Drugs of Abuse Screen: pre-study and at each check-in Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.
Exclusion criteria
* Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study. * Subjects whose clinical laboratory test values are greater than 20% outside the normal range on retesting, the subject will not be significant. * Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study. * All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each study period check-in. subjects found to have urin concentrations of any of the tested drugs will not be allowed to participate. * Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study. * Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate. * Subjects who do not tolerate venipuncture will not be allowed to participate. * Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is require. * Females will not be eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax - Maximum Observed Concentration | Blood samples collected over 36 hour period | Bioequivalence based on Cmax |
| AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Blood samples collected over 36 hour period | Bioequivalence based on AUCinf |
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Blood samples collected over 36 hour period | Bioequivalence based on AUC0-t |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Finasteride (Test) First Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period | 16 |
| Proscar® (Reference) First Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout | Protocol Violation | 1 | 0 |
| Washout | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Finasteride (Test) First | Proscar® (Reference) First | 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 | 9 Participants | 11 Participants | 20 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 4 Participants | 6 Participants |
| Region of Enrollment United States | 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 |
Outcome results
Primary
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 36 hour period
Population: Data from all subjects who completed the study were included in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finasteride | AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | 247.327 ng*h/mL | Standard Deviation 90.563 |
| Proscar® | AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | 250.822 ng*h/mL | Standard Deviation 87.883 |
90% CI: [94.9, 102]
Primary
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Bioequivalence based on AUCinf
Time frame: Blood samples collected over 36 hour period
Population: Data from all subjects who completed the study were included in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finasteride | AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | 252.848 ng*h/mL | Standard Deviation 97.525 |
| Proscar® | AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | 256.783 ng*h/mL | Standard Deviation 94.167 |
90% CI: [94.7, 102]
Primary
Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Time frame: Blood samples collected over 36 hour period
Population: Data from all subjects who completed the study were included in the statistical analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finasteride | Cmax - Maximum Observed Concentration | 35.550 ng/mL | Standard Deviation 10.17 |
| Proscar® | Cmax - Maximum Observed Concentration | 35.393 ng/mL | Standard Deviation 8.147 |
90% CI: [92.6, 105]