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

Warner Chilcott538 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

538

Conditions

Osteoporosis

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Research Site

San Diego, California, United States

Research Site

Fort Myers, Florida, United States

Research Site

Miramar, Florida, United States

Research Site

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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

Time frame: 72 hours post-dose

Data from ClinicalTrials.gov

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