Trial Outcomes & Findings for Cilostazol 50 mg Tablets Under Fasting Conditions (NCT NCT00839930)

NCT ID: NCT00839930

Last Updated: 2024-08-20

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: Blood samples collected over 72 hour period
• Results posted on: 2024-08-20

Participant Flow

Participant milestones

Measure	Cilostazol (Test) First Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period	Pletal® (Reference) First Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
First Intervention STARTED	15	15
First Intervention COMPLETED	15	15
First Intervention NOT COMPLETED	0	0
Washout: 7 Days STARTED	15	15
Washout: 7 Days COMPLETED	15	15
Washout: 7 Days NOT COMPLETED	0	0
Second Intervention STARTED	15	15
Second Intervention COMPLETED	15	15
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cilostazol 50 mg Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Cilostazol (Test) First n=15 Participants Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period	Pletal® (Reference) First n=15 Participants Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period	Total n=30 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 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	6 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Cilostazol n=30 Participants Cilostazol 50 mg Tablets (test)dosed in either period	Pletal® n=30 Participants Pletal® 50 mg Tablets (reference) dosed in either period
Cmax - Maximum Observed Concentration	376.46 ng/mL Standard Deviation 115.88	398.06 ng/mL Standard Deviation 108.07

PRIMARY outcome

Timeframe: Blood samples collected over 72 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	Cilostazol n=30 Participants Cilostazol 50 mg Tablets (test)dosed in either period	Pletal® n=30 Participants Pletal® 50 mg Tablets (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	5010.17 ng*h/mL Standard Deviation 1508.03	5176.83 ng*h/mL Standard Deviation 1435.42

PRIMARY outcome

Timeframe: Blood samples collected over 72 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	Cilostazol n=30 Participants Cilostazol 50 mg Tablets (test)dosed in either period	Pletal® n=30 Participants Pletal® 50 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	4618.70 ng*h/mL Standard Deviation 1416.60	4745.22 ng*h/mL Standard Deviation 1370.01

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