Trial Outcomes & Findings for Cilostazol 100 mg Tablet Formulations Under Fasting Conditions (NCT NCT00838630)

NCT ID: NCT00838630

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: Blood samples collected over 96 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Cilostazol (Test) First Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.	Pletal® (Reference) First Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
First Intervention STARTED	18	18
First Intervention COMPLETED	17	18
First Intervention NOT COMPLETED	1	0
Washout: 7 Days STARTED	17	18
Washout: 7 Days COMPLETED	16	18
Washout: 7 Days NOT COMPLETED	1	0
Second Intervention STARTED	16	18
Second Intervention COMPLETED	16	18
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Cilostazol (Test) First Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.	Pletal® (Reference) First Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
First Intervention Adverse Event	1	0
Washout: 7 Days Protocol Violation	1	0

Baseline Characteristics

Cilostazol 100 mg Tablet Formulations Under Fasting Conditions

Baseline characteristics by cohort

Measure	Cilostazol (Test) First n=18 Participants Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.	Pletal® (Reference) First n=18 Participants Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period	Total n=36 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	18 Participants n=5 Participants	18 Participants n=7 Participants	36 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Cilostazol n=34 Participants Cilostazol 100 mg Tablets (test) dosed in either period	Pletal® n=34 Participants Pletal® 100 mg Tablets (reference) dosed in either period
Cmax - Maximum Observed Concentration	536 ng/mL Standard Deviation 147	543 ng/mL Standard Deviation 145

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

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

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Cilostazol n=34 Participants Cilostazol 100 mg Tablets (test) dosed in either period	Pletal® n=34 Participants Pletal® 100 mg Tablets (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	8670 ng*h/mL Standard Deviation 3626	8974 ng*h/mL Standard Deviation 3147

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

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

Bioequivalence based on AUC0-t

Outcome measures

Measure	Cilostazol n=34 Participants Cilostazol 100 mg Tablets (test) dosed in either period	Pletal® n=34 Participants Pletal® 100 mg Tablets (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration	8430 ng*h/mL Standard Deviation 3507	8634 ng*h/mL Standard Deviation 3104

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