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NCT00932880 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 18 Fed, Healthy Adult Subjects
A Phase 1 study, sponsored by Torrent Pharmaceuticals Limited.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00932880: Completed Phase 1 study, sponsored by Torrent Pharmaceuticals Limited.
NCT00932880 is a Phase 1 study that has completed, run by Torrent Pharmaceuticals Limited. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00932880, a Phase 1 study, has completed, sponsored by Torrent Pharmaceuticals Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
* Objective: * The objective of this study was to compare the rate and extent of absorption of the test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.), with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.), when administered under fed conditions. * Study Design: * This was an open-label, randomized, two-way crossover study in which 18 healthy subjects were scheduled to receive a single dose of each of two treatments in two assigned dosing periods. Each dose administration was separated by a minimum 14-day washout period.
Interventions
- DRUG Norvasc
- DRUG Amlodipine Besylate
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
What the finished NCT00932880 record still lists
NCT00932880 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 2 interventions - of which Norvasc is the first listed.
NCT00932880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00932880 about?
NCT00932880 is a clinical study titled "Study to Evaluate the Bioavailability of the Test Formulation of Amlodipine 10 mg Tablets (Torrent Pharmaceuticals Limited) Compared to a 10 mg Dose of Norvasc® (Pfizer) in 18 Fed, Healthy Adult Subjects". * Objective: * The objective of this study was to compare the rate and extent of absorption of the test formulation, amlodipine besylate 10 mg tablets (Torrent Pharmaceuticals Ltd.), with that of the marketed reference product, Norvasc® 10 mg tablets (Pfizer, Inc.), when administered under fed co...
What is the current status of trial NCT00932880?
This trial is currently completed. It is a Phase 1 study.
What interventions are being tested in trial NCT00932880?
The interventions under investigation include: Norvasc (DRUG), Amlodipine Besylate (DRUG).
Who is sponsoring clinical trial NCT00932880?
This trial is sponsored by Torrent Pharmaceuticals Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.