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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.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finasteride | Experimental | Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period |
|
| Proscar® | Active Comparator | Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finasteride 5 mg tablets | Drug | 1 x 5 mg, single dose fasting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | Blood samples collected over 36 hour period |
| AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUCinf | Blood samples collected over 36 hour period |
| 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 | Blood samples collected over 36 hour period |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| So Ran Hong, M.D. | Novum Pharmaceutical Research Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novum Pharmaceutical Research Services | Houston | Texas | 77042 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Finasteride (Test) First | Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period |
| FG001 | Proscar® (Reference) First | Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Finasteride (Test) First | Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period |
| BG001 | Proscar® (Reference) First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jun 2009 | Mean | Standard Deviation | ng/mL | Blood samples collected over 36 hour period |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Biopharmaceutics | Teva Pharmaceuticals USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
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| ID | Term |
|---|---|
| D018120 | Finasteride |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| PROSCAR® |
| Drug |
1 x 5 mg, single dose fasting |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUCinf | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jun 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 36 hour period |
|
|
|
|
| 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 | Data from all subjects who completed the study were included in the statistical analysis. | Posted | Jun 2009 | Mean | Standard Deviation | ng*h/mL | Blood samples collected over 36 hour period |
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Principal Investigator is not permitted to discuss or publish trial results.
| D011083 |
| Polycyclic Compounds |
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |