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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00846196

Enrollment

538

Registered

2009-02-18

Start date

2009-01-31

Completion date

2009-05-31

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Brief summary

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.

Interventions

DRUGrisedronate 35 mg DR (Commercial Tablet)

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

DRUGrisedronate DR (Phase III clinical supply)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations.	72 hours post-dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026