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

NCT00846196 | Completed Phase 1

• 1 other identifier: 2008119
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 6

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

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

  72 hours post-dose

Study Arms (2)

2

EXPERIMENTAL

one commercial risedronate 35 mg DR tablet

Drug: risedronate 35 mg DR (Commercial Tablet)

1

ACTIVE COMPARATOR

one Phase III risedronate 35 mg DR tablet

Drug: risedronate DR (Phase III clinical supply)

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

Also known as: Phase III clinical supply

1

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

Also known as: Commercial Tablet

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Warner Chilcott: lead
• Sanofi: collaborator

Study Sites (6)

Research Site

San Diego, California, 92123, United States

Location

Research Site

Fort Myers, Florida, 33901, United States

Location

Research Site

Miramar, Florida, 33025, United States

Location

Research Site

Omaha, Nebraska, 68154, United States

Location

Research site

Austin, Texas, 78752, United States

Location

Research Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chantell Wilson, PhD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 18, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (6)