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NCT00835081 · ClinicalTrials.gov registry record · Phase 1
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
A Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 2
- Study locations
NCT00835081: Completed Phase 1 study of Healthy, sponsored by Teva Pharmaceuticals U.
NCT00835081 is a Phase 1 study of Healthy that has completed, run by Teva Pharmaceuticals U. The registered enrollment target is 26 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835081, a Phase 1 study of Healthy, has completed, sponsored by Teva Pharmaceuticals U.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fed conditions.
Primary Outcome
Bioequivalence based on Cmax.
Conditions Studied
Interventions
- DRUG Cefadroxil 500 mg Capsules
- DRUG DURICEF® capsules 500 mg
Study Locations (2)
Texas
- Bioassay Laboratory, Inc. - Houston
Ontario
- Biovail Contract Research - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2004-09 |
| Est. Completion | 2004-10 |
| Phase | Phase 1 |
What the finished NCT00835081 record still lists
NCT00835081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Cefadroxil 500 mg Capsules is the first listed.
NCT00835081 reports a single indexed study location in Texas, Ontario.
Frequently Asked Questions
What is clinical trial NCT00835081 about?
NCT00835081 is a clinical study titled "Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.". The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and...
What is the current status of trial NCT00835081?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2004-09. Estimated completion is 2004-10.
What conditions does trial NCT00835081 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00835081?
The interventions under investigation include: Cefadroxil 500 mg Capsules (DRUG), DURICEF® capsules 500 mg (DRUG).
Who is sponsoring clinical trial NCT00835081?
This trial is sponsored by Teva Pharmaceuticals U, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00835081 being conducted?
This trial has 2 study locations across Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00835081's enrollment target sits among peer trials
26 760th of 1090 higher than 314 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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