NCT01069913

Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient

A Pharmacokinetics Profile Determination of BG00012 Standard Formulation and the BG00012 Active Pharmaceutical Ingredient (API) After a Single Oral Dose Administered to Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Biogen · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BG00012	Sequence 1: Oral 240 mg BG00012 Standard Formulation \& Following 7 day washout period, 240 mg BG00012 API. Sequence 2: 240 mg BG00012 API \& Following 7 day washout period, 240 mg BG00012 Standard Formulation.

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-10-01
• Completion: 2010-01-01
• First posted: 2010-02-17
• Last updated: 2010-02-17