Trials / Completed
CompletedNCT01632449
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.
- 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 single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.
Detailed description
This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Test product | Dimethyl Fumarate (BG00012) |
| DRUG | Reference product | Dimethyl Fumarate (BG00012) |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2012-09-01
- Completion
- 2012-09-01
- First posted
- 2012-07-03
- Last updated
- 2013-05-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01632449. Inclusion in this directory is not an endorsement.