NCT01019590

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

November 11, 2009

Last Update Submit

April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.

    blood collections through 48 hours

Study Arms (2)

1

EXPERIMENTAL

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg

Drug: Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg

2

ACTIVE COMPARATOR

Benicar HCT ® Tablets 40 mg/25 mg

Drug: Benicar HCT ® Tablets 40 mg/25 mg

Interventions

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mgDRUG
1
Benicar HCT ® Tablets 40 mg/25 mgDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRACS Institute Ltd.

Fargo, North Dakota, 58104, United States

Location

Related Links

MeSH Terms

Interventions

Olmesartan MedoxomilHydrochlorothiazide

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Alan K Copa, Pharm. D.

    PRACS Institute Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 11, 2009

First Posted

November 25, 2009

Study Start

November 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

US(1)