Trial Outcomes & Findings for Pravastatin Sodium 80 mg Tablets Under Fasting Conditions (NCT NCT00830258)

NCT ID: NCT00830258

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 60 participants
• Primary outcome timeframe: Blood samples collected over 16 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Pravastatin (Test) First Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period	Pravachol® (Reference) First Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
First Intervention STARTED	30	30
First Intervention COMPLETED	29	30
First Intervention NOT COMPLETED	1	0
Washout: 7 Days STARTED	29	30
Washout: 7 Days COMPLETED	28	30
Washout: 7 Days NOT COMPLETED	1	0
Second Intervention STARTED	28	30
Second Intervention COMPLETED	28	30
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Pravastatin (Test) First Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period	Pravachol® (Reference) First Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
First Intervention Adverse Event	1	0
Washout: 7 Days Protocol Violation	1	0

Baseline Characteristics

Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Pravastatin (Test) First n=30 Participants Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period	Pravachol® (Reference) First n=30 Participants Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period	Total n=60 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	30 Participants n=5 Participants	30 Participants n=7 Participants	60 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	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 16 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Pravastatin n=58 Participants Pravastatin 80 mg Tablet (test) dosed in either period	Pravachol® n=58 Participants Pravachol® 80 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Pravastatin in Plasma	191.857 ng/mL Standard Deviation 109.746	188.460 ng/mL Standard Deviation 123.226

PRIMARY outcome

Timeframe: Blood samples collected over 16 hour period

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

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Pravastatin n=58 Participants Pravastatin 80 mg Tablet (test) dosed in either period	Pravachol® n=58 Participants Pravachol® 80 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	409.224 ng*h/mL Standard Deviation 199.894	378.930 ng*h/mL Standard Deviation 206.667

PRIMARY outcome

Timeframe: Blood samples collected over 16 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	Pravastatin n=58 Participants Pravastatin 80 mg Tablet (test) dosed in either period	Pravachol® n=58 Participants Pravachol® 80 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)	404.202 ng*h/mL Standard Deviation 199.159	373.720 ng*h/mL Standard Deviation 204.837

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