Trial Outcomes & Findings for Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions (NCT NCT00836056)

NCT ID: NCT00836056

Last Updated: 2024-08-19

Results Overview

Cmax - Maximum Observed Concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Blood samples collected over 24 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Clindamycin (Test) First Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period	Cleocin® (Reference) First Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
First Intervention STARTED	12	12
First Intervention COMPLETED	11	12
First Intervention NOT COMPLETED	1	0
Washout: 7 Days STARTED	11	12
Washout: 7 Days COMPLETED	11	12
Washout: 7 Days NOT COMPLETED	0	0
Second Intervention STARTED	11	12
Second Intervention COMPLETED	11	12
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Clindamycin (Test) First Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period	Cleocin® (Reference) First Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
First Intervention Adverse Event	1	0

Baseline Characteristics

Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions

Baseline characteristics by cohort

Measure	Clindamycin (Test) First n=12 Participants Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period	Cleocin® (Reference) First n=12 Participants Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period	Total n=24 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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 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	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

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

Cmax - Maximum Observed Concentration

Outcome measures

Measure	Clindamycin n=23 Participants Clindamycin 300 mg Capsule (test) dosed in either period	Cleocin® n=23 Participants Cleocin® 300 mg Capsule (reference) dosed in either period
Bioequivalence Based on Cmax	3008.88 ng/mL Standard Deviation 860.12	3086.02 ng/mL Standard Deviation 988.84

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

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

AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)

Outcome measures

Measure	Clindamycin n=23 Participants Clindamycin 300 mg Capsule (test) dosed in either period	Cleocin® n=23 Participants Cleocin® 300 mg Capsule (reference) dosed in either period
Bioequivalence Based on AUCinf	10646.98 ng*h/mL Standard Deviation 3549.49	10890.41 ng*h/mL Standard Deviation 3297.46

PRIMARY outcome

Timeframe: Blood samples collected over 24 hour period

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

AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration

Outcome measures

Measure	Clindamycin n=23 Participants Clindamycin 300 mg Capsule (test) dosed in either period	Cleocin® n=23 Participants Cleocin® 300 mg Capsule (reference) dosed in either period
Bioequivalence Based on AUC0-t	10218.56 ng*h/mL Standard Deviation 3500.68	10504.80 ng*h/mL Standard Deviation 3172.90

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