Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Actavis Inc.
- Enrollment
- 40
- 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 nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.
Detailed Description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Single Dose Two-Way Crossover Fasted 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
- 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