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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00649519 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00649519 record still lists
NCT00649519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00649519's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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