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NCT01020214 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT01020214: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

NCT01020214 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01020214, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

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 fasting conditions.

Conditions Studied

Healthy

Interventions

  • DRUG Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg
  • DRUG Benicar HCT® Tablets 40 mg/25 mg

Study Locations (1)

North Dakota

  • PRACS Institute Ltd. - Fargo

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2006-11
Est. Completion 2006-11
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT01020214 record still lists

NCT01020214 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg is the first listed.

NCT01020214 reports a single indexed study location in North Dakota.

Frequently Asked Questions

What is clinical trial NCT01020214 about?

NCT01020214 is a clinical study titled "Fasting 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 fasting conditions.

What is the current status of trial NCT01020214?

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 conditions does trial NCT01020214 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT01020214?

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 NCT01020214?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01020214 being conducted?

This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01020214's enrollment target sits among peer trials

36 595th of 1090 higher than 469 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy 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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Related registry views

Source: ClinicalTrials.gov NCT01020214, the US trial registry maintained by the National Library of Medicine. NCT01020214 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.