Trials / Completed
CompletedNCT01420458
Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.
Detailed description
This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Experimental | Bioequivalence of two drug formulations |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2011-08-19
- Last updated
- 2011-11-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01420458. Inclusion in this directory is not an endorsement.