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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01019590
The ClinicalTrials.gov registry entry for NCT01019590 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg is the first listed.
NCT01019590 reports 0 study locations.
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.
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