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Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions

NCT01712139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-01-23

No results posted yet for this study

Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fasted conditions.

Conditions

Interventions

DRUG

Irbesartan and Hydrochlorothiazide

DRUG

Avalide

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • Jolene K Berg, MD · Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01712139 on ClinicalTrials.gov