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

NCT01069913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2010-02-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Biogen Idec Medical Director · Biogen Idec, Cambridge, MA USA

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-10-31
Completion
2010-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01069913 on ClinicalTrials.gov