Trial Outcomes & Findings for A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions (NCT NCT00830206)

NCT ID: NCT00830206

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 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® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin 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	39
Washout: 21 Days NOT COMPLETED	1	1
Second Intervention STARTED	39	39
Second Intervention COMPLETED	39	39
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

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

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Azithromycin (Test) First n=40 Participants Azithromycin 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® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin 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	40 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized White	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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: One subject was excluded from statistical analysis due to emesis during sample collection period.

Bioequivalence based on Cmax

Outcome measures

Measure	Azithromycin n=77 Participants Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period	Zithromax® n=77 Participants Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
Cmax - Maximum Observed Concentration	465.66 ng/mL Standard Deviation 222.06	449.85 ng/mL Standard Deviation 192.95

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: One subject was excluded from statistical analysis due to emesis during sample collection period.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Azithromycin n=77 Participants Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period	Zithromax® n=77 Participants Zithromax® 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)	4896.65 ng*h/mL Standard Deviation 1620.06	5022.64 ng*h/mL Standard Deviation 2145.80

PRIMARY outcome

Timeframe: Blood samples collected over 168 hour period

Population: One subject was excluded from statistical analysis due to emesis during sample collection period.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Azithromycin n=77 Participants Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period	Zithromax® n=77 Participants Zithromax® 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)	4357.47 ng*h/mL Standard Deviation 1492.87	4428.53 ng*h/mL Standard Deviation 1936.89

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