Trial Outcomes & Findings for Azithromycin 600 Mg Tablets, Fed (NCT NCT00834132)

NCT ID: NCT00834132

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Blood samples collected over 168 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Azithromycin (Test) First Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period	Zithromax® (Reference) First Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
First Intervention STARTED	12	12
First Intervention COMPLETED	12	12
First Intervention NOT COMPLETED	0	0
Washout: 21 Days STARTED	12	12
Washout: 21 Days COMPLETED	12	12
Washout: 21 Days NOT COMPLETED	0	0
Second Intervention STARTED	12	12
Second Intervention COMPLETED	12	12
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Azithromycin 600 Mg Tablets, Fed

Baseline characteristics by cohort

Measure	Azithromycin (Test) First n=12 Participants Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period	Zithromax® (Reference) First n=12 Participants Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (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	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Black	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

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

Bioequivalence based on Cmax

Outcome measures

Measure	Azithromycin n=24 Participants Azithromycin 600 mg tablet (test) dosed in either period	Zithromax® n=24 Participants Zithromax® 600 mg tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Azithromycin in Plasma	561.556 ng/mL Standard Deviation 199.349	592.311 ng/mL Standard Deviation 255.261

PRIMARY outcome

Timeframe: Blood samples collected over 168 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	Azithromycin n=24 Participants Azithromycin 600 mg tablet (test) dosed in either period	Zithromax® n=24 Participants Zithromax® 600 mg tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma	7025.920 ng*h/mL Standard Deviation 1583.546	6964.092 ng*h/mL Standard Deviation 1621.163

PRIMARY outcome

Timeframe: Blood samples collected over 168 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	Azithromycin n=24 Participants Azithromycin 600 mg tablet (test) dosed in either period	Zithromax® n=24 Participants Zithromax® 600 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)- Azithromycin in Plasma	6132.710 ng*h/mL Standard Deviation 1483.937	6063.795 ng*h/mL Standard Deviation 1436.447

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