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NCT00932763 · 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 22 Fasted, Healthy Adult Subjects
A Phase 1 study of Healthy, sponsored by Torrent Pharmaceuticals Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Study location
NCT00932763: Completed Phase 1 study of Healthy, sponsored by Torrent Pharmaceuticals Limited.
NCT00932763 is a Phase 1 study of Healthy that has completed, run by Torrent Pharmaceuticals Limited. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00932763, a Phase 1 study of Healthy, has completed, sponsored by Torrent Pharmaceuticals Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1
- Study location
Study Summary
* Objective: * The objective of this study was to assess the relative bioavailability of two formulations of immediate release amlodipine 10 mg under fasted conditions, in healthy subjects. * Study Design: * This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover study.Twenty-two healthy subjects were enrolled. Subjects who successfully completed the screening process checked into the research center the night before first dose. Subjects who continued to meet inclusion/exclusion criteria the morning of dose were assigned a subject number, based on the order in which they successfully completed the screening process and procedures as outlined in the study protocol. Subjects were randomly assigned to a treatment sequence and received two separate single-dose administrations of study medication, one treatment per period,according to the randomization schedule. Dosing days were separated by a washout period of at least 14 days. Subjects received each of the treatments listed below during the two treatment periods following an overnight fast of at least 10 hours: amlodipine by Torrent Pharmaceuticals Ltd. and Norvasc by Pfizer, Inc.
Conditions Studied
Interventions
- DRUG Amlodipine besylate
- DRUG Norvasc
Study Locations (1)
Texas
- CEDRA Clinical Research, LLC - San Antonio
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00932763
The ClinicalTrials.gov registry entry for NCT00932763 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Torrent Pharmaceuticals Limited, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Amlodipine besylate is the first listed.
NCT00932763 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00932763 about?
NCT00932763 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 22 Fasted, Healthy Adult Subjects". * Objective: * The objective of this study was to assess the relative bioavailability of two formulations of immediate release amlodipine 10 mg under fasted conditions, in healthy subjects. * Study Design: * This was an open-label, single-dose, 2-treatment, 2-period, randomized, crossover stud...
What is the current status of trial NCT00932763?
This trial is currently completed. It is a Phase 1 study.
What conditions does trial NCT00932763 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00932763?
The interventions under investigation include: Amlodipine besylate (DRUG), Norvasc (DRUG).
Who is sponsoring clinical trial NCT00932763?
This trial is sponsored by Torrent Pharmaceuticals Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00932763 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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