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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 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.

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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

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

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT01020214

The ClinicalTrials.gov registry entry for NCT01020214 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, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.