Trial Outcomes & Findings for Azithromycin 600 Mg Tablets, Fasting (NCT NCT00834756)

NCT ID: NCT00834756

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 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	18	18
First Intervention COMPLETED	17	18
First Intervention NOT COMPLETED	1	0
Washout: 21 Days STARTED	17	18
Washout: 21 Days COMPLETED	16	18
Washout: 21 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	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 Adverse Event	1	0
Washout: 21 Days Withdrawal by Subject	1	0

Baseline Characteristics

Azithromycin 600 Mg Tablets, Fasting

Baseline characteristics by cohort

Measure	Azithromycin (Test) First n=18 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=18 Participants Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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 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=34 Participants Azithromycin 600 mg tablet (test) dosed in either period	Zithromax® n=34 Participants Zithromax® 600 mg tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration - Azithromycin in Plasma	522.255 ng/mL Standard Deviation 170.503	544.024 ng/mL Standard Deviation 159.688

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=34 Participants Azithromycin 600 mg tablet (test) dosed in either period	Zithromax® n=34 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	6894.151 ng*h/mL Standard Deviation 1715.464	6989.682 ng*h/mL Standard Deviation 2101.213

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=34 Participants Azithromycin 600 mg tablet (test) dosed in either period	Zithromax® n=34 Participants Zithromax® 600 mg tablet (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration (Per Participant) - Azithromycin in Plasma	6190.268 ng*h/mL Standard Deviation 1501.185	6167.730 ng*h/mL Standard Deviation 1800.711

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