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NCT01019590 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01019590: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT01019590 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01019590, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed conditions.
Interventions
- DRUG Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg
- DRUG Benicar HCT ® Tablets 40 mg/25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-11 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
What the finished NCT01019590 record still lists
NCT01019590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg is the first listed.
NCT01019590 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01019590 about?
NCT01019590 is a clinical study titled "Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg". The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed conditions.
What is the current status of trial NCT01019590?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2006-11. Estimated completion is 2006-11.
What interventions are being tested in trial NCT01019590?
The interventions under investigation include: Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg (DRUG), Benicar HCT ® Tablets 40 mg/25 mg (DRUG).
Who is sponsoring clinical trial NCT01019590?
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 NCT01019590's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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