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NCT00835549 · ClinicalTrials.gov registry record · Phase 1
Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00835549: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00835549 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835549, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects under non-fasting conditions.
Primary Outcome
Bioequivalence based on Cmax.
Interventions
- DRUG Cefdinir for oral suspension 250 mg/5mL
- DRUG OMNICEF® for oral suspension 250 mg/5mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2005-03 |
| Est. Completion | 2005-03 |
| Phase | Phase 1 |
What the finished NCT00835549 record still lists
NCT00835549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Cefdinir for oral suspension 250 mg/5mL is the first listed.
NCT00835549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835549 about?
NCT00835549 is a clinical study titled "Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting". The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects under non-fasting condit...
What is the current status of trial NCT00835549?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2005-03. Estimated completion is 2005-03.
What interventions are being tested in trial NCT00835549?
The interventions under investigation include: Cefdinir for oral suspension 250 mg/5mL (DRUG), OMNICEF® for oral suspension 250 mg/5mL (DRUG).
Who is sponsoring clinical trial NCT00835549?
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 NCT00835549's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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