Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00846196

Osteoporosis

COMPLETED PHASE1

Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

NCT00358176

Osteoporosis Postmenopausal

COMPLETED PHASE3

Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

NCT00577837

Postmenopausal

COMPLETED PHASE2

Risedronate in Postmenopausal Women With Low Bone Density

NCT00351091

OSTEOPOROSIS, POSTMENOPAUSAL

COMPLETED PHASE2

Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis

NCT00619957

Other Osteoporosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The data to support the interchangeability of one risedronate 150 mg tablet versus two risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in vitro dissolution and an in vivo study, which showed risedronate absorption is not dissolution rate limited. These results suggest that monthly dosing of risedronate may be accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75 mg tablets. The purpose of this study is to provide additional clinical data to support the interchangeability of these 2 dose regimens.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast

Group Type EXPERIMENTAL

Risedronate

Intervention Type DRUG

1 risedronate 150 mg tablet administered orally

2

Two risedronate 75 mg tablets administered as a single oral dose after an overnight (10 hour) fast, followed by a 4 hour post-dose fast

Group Type ACTIVE_COMPARATOR

Risedronate

Intervention Type DRUG

2 risedronate 75 mg tablets administered as a single oral dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Risedronate

1 risedronate 150 mg tablet administered orally

Intervention Type DRUG

Risedronate

2 risedronate 75 mg tablets administered as a single oral dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* be in good general health based on medical history, physical examination, and laboratory evaluation
* have a body mass index (BMI) ≤ 32 kg/m2 at screening

Exclusion Criteria

* has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
* has any disease or surgery known to alter normal GI structure or function
* has a creatinine clearance of \< 60 mL/min, estimated by serum creatinine using the Cockcroft-Gault formula

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes