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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2006-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01020214

Healthy

COMPLETED PHASE1

Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

NCT00648219

Healthy

COMPLETED PHASE1

Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablets Under Fed Conditions

NCT03319706

Healthy Subjects

COMPLETED PHASE1

Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

NCT00649623

Healthy

COMPLETED PHASE1

Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablet Under Fasting Conditions

NCT03318354

Healthy Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg

Group Type EXPERIMENTAL

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg

Intervention Type DRUG

2

Benicar HCT ® Tablets 40 mg/25 mg

Group Type ACTIVE_COMPARATOR

Benicar HCT ® Tablets 40 mg/25 mg

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg

Intervention Type DRUG

Benicar HCT ® Tablets 40 mg/25 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes