A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects

Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, San Diego, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

male or female, 18 to 65 years of age
if female, non-lactating and either surgically sterile or postmenopausal
body mass index less than or equal to 32 kg/m2 at screening

Exclusion criteria

no use of a bisphosphonate within 1 month
no history of GI disease
no use of any medications within 7-14 days prior to scheduled dosing day

Treatment and study plan

risedronate DR (Phase III clinical supply)

Drug

Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast

Other names: Phase III clinical supply

risedronate 35 mg DR (Commercial Tablet)

Drug

Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast

Other names: Commercial Tablet

Primary outcomes

Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations.

Time frame: 72 hours post-dose

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

Sanofi

Registry information

Official study title

A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Feb 18, 2009
Registry last updated: Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed