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NCT01499758 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fasting Conditions.
A Phase 1 study, sponsored by Ranbaxy Laboratories Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01499758: Completed Phase 1 study, sponsored by Ranbaxy Laboratories Limited.
NCT01499758 is a Phase 1 study that has completed, run by Ranbaxy Laboratories Limited. 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
NCT01499758, a Phase 1 study, has completed, sponsored by Ranbaxy Laboratories Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of 80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80 mg tablet) in healthy adult subjects when administered under fasting conditions.
Interventions
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
What the finished NCT01499758 record still lists
NCT01499758 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 1 intervention - of which Atorvastatin is the first listed.
NCT01499758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01499758 about?
NCT01499758 is a clinical study titled "A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fasting Conditions.". This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of 80 mg LIPITOR® Tablets (containing...
What is the current status of trial NCT01499758?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2009-10. Estimated completion is 2009-12.
What interventions are being tested in trial NCT01499758?
The interventions under investigation include: Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT01499758?
This trial is sponsored by Ranbaxy Laboratories Limited, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01499758'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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