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NCT01499771 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions
A Phase 1 study, sponsored by Ranbaxy Laboratories Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01499771: Completed Phase 1 study, sponsored by Ranbaxy Laboratories Limited.
NCT01499771 is a Phase 1 study that has completed, run by Ranbaxy Laboratories Limited. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01499771, 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 fed conditions.
Interventions
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01499771
The ClinicalTrials.gov registry entry for NCT01499771 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ranbaxy Laboratories Limited, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Atorvastatin is the first listed.
NCT01499771 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01499771 about?
NCT01499771 is a clinical study titled "A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed 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 NCT01499771?
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 NCT01499771?
The interventions under investigation include: Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT01499771?
This trial is sponsored by Ranbaxy Laboratories Limited, which has 44 total clinical trials registered on ClinicalTrials.gov.
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