A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
Phase 1
Completed
- Conditions
- Osteoporosis
- Interventions
- Registration Number
- NCT00846196
- Lead Sponsor
- Warner Chilcott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 538
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 risedronate DR (Phase III clinical supply) one Phase III risedronate 35 mg DR tablet 2 risedronate 35 mg DR (Commercial Tablet) one commercial risedronate 35 mg DR tablet
- Primary Outcome Measures
Name Time Method Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations. 72 hours post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Research site
🇺🇸Austin, Texas, United States
Research Site
🇺🇸Dallas, Texas, United States