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

Warner Chilcott

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: risedronate 35 mg DR (Commercial Tablet); Drug: risedronate DR (Phase III clinical supply)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00846196

2008119

Details and patient eligibility

About

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.

Enrollment: 538 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

538 participants in 2 patient groups

2

Experimental group

Description:

one commercial risedronate 35 mg DR tablet

Treatment:

Drug: risedronate 35 mg DR (Commercial Tablet)

1

Active Comparator group

Description:

one Phase III risedronate 35 mg DR tablet

Treatment:

Drug: risedronate DR (Phase III clinical supply)