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NCT00834535 · ClinicalTrials.gov registry record · Phase 1
Cefdinir Capsules 300 mg, Non-fasting
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00834535: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00834535 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
NCT00834535, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 300 mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a single oral dose (1 x 300mg capsule) in healthy adult subjects administered under non-fasting conditions.
Primary Outcome
Bioequivalence based on Cmax.
Interventions
- DRUG Cefdinir Capsules 300 mg
- DRUG OMNICEF® Capsule 300 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2005-07 |
| Est. Completion | 2005-08 |
| Phase | Phase 1 |
What the finished NCT00834535 record still lists
NCT00834535 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 Capsules 300 mg is the first listed.
NCT00834535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00834535 about?
NCT00834535 is a clinical study titled "Cefdinir Capsules 300 mg, Non-fasting". This study will compare the relative bioavailability (rate and extent of absorption) of 300 mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of OMNICEF® Capsules by CEPH International Corporation for Abbott Laboratories following a single oral dose (1 x 300mg c...
What is the current status of trial NCT00834535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2005-07. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00834535?
The interventions under investigation include: Cefdinir Capsules 300 mg (DRUG), OMNICEF® Capsule 300 mg (DRUG).
Who is sponsoring clinical trial NCT00834535?
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 NCT00834535'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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