Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Actavis Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate and Extend of Absorption
Study Overview
Brief Summary
The purpose of this study is to evaluate the relative bioavailability of two formulations of nabumetone tablets to establish their average bioequivalence
Detailed Description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Single Dose Two-Way Crossover Fed Bioequivalence Study of
Nabumetone 750 mg Tablets in Healthy Volunteers Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Nabumetone 750 mg tablets, single dose
Intervention: Nabumetone 750 mg tablets, single dose (Drug)
B
Nabumetone 750 mg tablets, single dose
Intervention: Nabumetone 750 mg tablets, single dose (Drug)
Outcomes
Primary Outcomes
Rate and Extend of Absorption
Time Frame: 120 hours
Secondary Outcomes
No secondary outcomes reported