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NCT00601315 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions
A NA study of Infection, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00601315: Completed NA study of Infection, sponsored by Roxane Laboratories.
NCT00601315 is a NA study of Infection that has completed, run by Roxane Laboratories. The registered enrollment target is 40 participants, below the 725-participant average among 41 other Infection trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601315, a NA study of Infection, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.
Conditions Studied
Interventions
- DRUG Clarithromycin
Study Locations (1)
Arizona
- MDS Pharma Services - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2003-04 |
| Est. Completion | 2003-05 |
| Phase | NA |
What the finished NCT00601315 record still lists
NCT00601315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 725-participant average among 41 other Infection trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Infection appearing as the primary indexed condition, and to 1 intervention - of which Clarithromycin is the first listed.
NCT00601315 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT00601315 about?
NCT00601315 is a clinical study titled "Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions". The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.
What is the current status of trial NCT00601315?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2003-04. Estimated completion is 2003-05.
What conditions does trial NCT00601315 study?
This clinical trial studies the following conditions: Infection.
What interventions are being tested in trial NCT00601315?
The interventions under investigation include: Clarithromycin (DRUG).
Who is sponsoring clinical trial NCT00601315?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00601315 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Infection
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 NCT00601315's enrollment target sits among peer trials
40 30th of 41 higher than 11 of 41 other Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection 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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