Trial Outcomes & Findings for Finasteride 5 mg Tablets, Non-fasting (NCT NCT00835796)

NCT ID: NCT00835796

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 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	10	10
First Intervention COMPLETED	10	9
First Intervention NOT COMPLETED	0	1
Washout STARTED	10	9
Washout COMPLETED	10	9
Washout NOT COMPLETED	0	0
Second Intervention STARTED	10	9
Second Intervention COMPLETED	10	9
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
First Intervention Withdrawal by Subject	0	1

Baseline Characteristics

Finasteride 5 mg Tablets, Non-fasting

Baseline characteristics by cohort

Measure	Finasteride (Test) First n=10 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=10 Participants Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period	Total n=20 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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 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=19 Participants Finasteride 5 mg Tablet (test) dosed in either period	Proscar® n=19 Participants Proscar® 5 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	33.037 ng/mL Standard Deviation 8.539	32.242 ng/mL Standard Deviation 6.885

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=19 Participants Finasteride 5 mg Tablet (test) dosed in either period	Proscar® n=19 Participants Proscar® 5 mg Tablet (reference) dosed in either period
AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	274.802 ng*h/mL Standard Deviation 118.843	280.371 ng*h/mL Standard Deviation 128.337

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=19 Participants Finasteride 5 mg Tablet (test) dosed in either period	Proscar® n=19 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)	266.412 ng*h/mL Standard Deviation 107.650	271.183 ng*h/mL Standard Deviation 116.538

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