Trial Outcomes & Findings for Finasteride 5 mg Tablets Under Fasting Conditions (NCT NCT00835666)

NCT ID: NCT00835666

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: Blood samples collected over 36 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Finasteride (Test) First Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period	Proscar® (Reference) First Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
First Intervention STARTED	16	16
First Intervention COMPLETED	16	16
First Intervention NOT COMPLETED	0	0
Washout STARTED	16	16
Washout COMPLETED	14	16
Washout NOT COMPLETED	2	0
Second Intervention STARTED	14	16
Second Intervention COMPLETED	14	16
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Finasteride (Test) First Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period	Proscar® (Reference) First Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
Washout Protocol Violation	1	0
Washout Withdrawal by Subject	1	0

Baseline Characteristics

Finasteride 5 mg Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Finasteride (Test) First n=16 Participants Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period	Proscar® (Reference) First n=16 Participants Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Finasteride n=30 Participants Finasteride 5 mg Tablet (test) dosed in either period	Proscar® n=30 Participants Proscar® 5 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	35.550 ng/mL Standard Deviation 10.170	35.393 ng/mL Standard Deviation 8.147

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUCinf

Outcome measures

Measure	Finasteride n=30 Participants Finasteride 5 mg Tablet (test) dosed in either period	Proscar® n=30 Participants Proscar® 5 mg Tablet (reference) dosed in either period
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	252.848 ng*h/mL Standard Deviation 97.525	256.783 ng*h/mL Standard Deviation 94.167

PRIMARY outcome

Timeframe: Blood samples collected over 36 hour period

Population: Data from all subjects who completed the study were included in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Finasteride n=30 Participants Finasteride 5 mg Tablet (test) dosed in either period	Proscar® n=30 Participants Proscar® 5 mg Tablet (reference) dosed in either period
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	250.822 ng*h/mL Standard Deviation 87.883

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER