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NCT00830336 · ClinicalTrials.gov registry record · Phase 1
A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT00830336: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00830336 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00830336, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, a division of Pfizer Inc. following a single oral 10 mL dose (400 mg) in healthy adult subjects administered under non-fasting conditions.
Primary Outcome
Bioequivalence based on Cmax
Interventions
- DRUG Azithromycin
- DRUG Zithromax®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2005-10 |
| Est. Completion | 2005-11 |
| Phase | Phase 1 |
What the finished NCT00830336 record still lists
NCT00830336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Azithromycin is the first listed.
NCT00830336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00830336 about?
NCT00830336 is a clinical study titled "A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions". The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with that of 200 mg/5 mL ZITHROMAX oral suspension distributed by Pfizer labs, ...
What is the current status of trial NCT00830336?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2005-10. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00830336?
The interventions under investigation include: Azithromycin (DRUG), Zithromax® (DRUG).
Who is sponsoring clinical trial NCT00830336?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00830336's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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