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NCT00649597 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00649597: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00649597 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00649597, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.
Interventions
- DRUG Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
- DRUG Lotensin HCT® Tablets 20 mg/25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2002-11 |
| Est. Completion | 2002-12 |
| Phase | Phase 1 |
What the finished NCT00649597 record still lists
NCT00649597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg is the first listed.
NCT00649597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00649597 about?
NCT00649597 is a clinical study titled "Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg". The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions.
What is the current status of trial NCT00649597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2002-11. Estimated completion is 2002-12.
What interventions are being tested in trial NCT00649597?
The interventions under investigation include: Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg (DRUG), Lotensin HCT® Tablets 20 mg/25 mg (DRUG).
Who is sponsoring clinical trial NCT00649597?
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 NCT00649597's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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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