Trial Outcomes & Findings for A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions (NCT NCT00830336)

NCT ID: NCT00830336

Last Updated: 2024-08-20

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 80 participants
• Primary outcome timeframe: Blood samples collected over 168 hour period
• Results posted on: 2024-08-20

Participant Flow

Participant milestones

Measure	Azithromycin (Test) First Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period	Zithromax® (Reference) First Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
First Intervention STARTED	40	40
First Intervention COMPLETED	40	40
First Intervention NOT COMPLETED	0	0
Washout: 21 Days STARTED	40	40
Washout: 21 Days COMPLETED	39	40
Washout: 21 Days NOT COMPLETED	1	0
Second Intervention STARTED	39	40
Second Intervention COMPLETED	39	40
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Azithromycin (Test) First Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period	Zithromax® (Reference) First Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
Washout: 21 Days Withdrawal by Subject	1	0

Baseline Characteristics

A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions

Baseline characteristics by cohort

Measure	Azithromycin (Test) First n=40 Participants Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period	Zithromax® (Reference) First n=40 Participants Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period	Total n=80 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	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized White	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander/Hawaiian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.

Bioequivalence based on Cmax

Outcome measures

Measure	Azithromycin n=77 Participants Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period	Zithromax® n=77 Participants Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
Cmax - Maximum Observed Concentration	560.56 ng/mL Standard Deviation 212.71	562.97 ng/mL Standard Deviation 254.40

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Azithromycin n=77 Participants Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period	Zithromax® n=77 Participants Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	5140.47 ng*h/mL Standard Deviation 1630.93	4884.55 ng*h/mL Standard Deviation 1599.27

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Azithromycin n=77 Participants Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period	Zithromax® n=77 Participants Zithromax® for Oral Suspension 200 mg/5 mL (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)	4555.91 ng*h/mL Standard Deviation 1502.93	4277.83 ng*h/mL Standard Deviation 1431.90

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