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NCT00649519 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT00649519 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 54 participants.
The verdict
NCT00649519, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.
Interventions
- DRUG Amlodipine and Benazepril HCl Capsules 10 mg/20 mg
- DRUG Lotrel® Capsules 10 mg/20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2004-05 |
| Est. Completion | 2004-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00649519
The ClinicalTrials.gov registry entry for NCT00649519 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Amlodipine and Benazepril HCl Capsules 10 mg/20 mg is the first listed.
NCT00649519 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00649519 about?
NCT00649519 is a clinical study titled "Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg". The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.
What is the current status of trial NCT00649519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2004-05. Estimated completion is 2004-05.
What interventions are being tested in trial NCT00649519?
The interventions under investigation include: Amlodipine and Benazepril HCl Capsules 10 mg/20 mg (DRUG), Lotrel® Capsules 10 mg/20 mg (DRUG).
Who is sponsoring clinical trial NCT00649519?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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