A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/7/2015 |
| Start Date: | June 2014 |
| End Date: | July 2014 |
| Contact: | Biogen Idec |
| Email: | clinicaltrials@biogenidec.com |
A Randomized, Double-Blind, Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers (Vifor SA and Biogen Idec OSD)
The primary objective of this study is to establish the bioequivalence of the test product
(BG00012 supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor
SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.
The secondary objectives of this study are to determine the safety and tolerability of the
test product compared to the reference product, to estimate PK parameters of the test
product and the reference product, and to estimate the intra-subject coefficient of
variation (CV%) of the referencd product for both area under the plasma concentration curve
(AUC) and peak plasma concentration (Cmax).
(BG00012 supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor
SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.
The secondary objectives of this study are to determine the safety and tolerability of the
test product compared to the reference product, to estimate PK parameters of the test
product and the reference product, and to estimate the intra-subject coefficient of
variation (CV%) of the referencd product for both area under the plasma concentration curve
(AUC) and peak plasma concentration (Cmax).
Key Inclusion Criteria:
- BMI of 19.0 to 30.0 kg/m2, inclusive
- Subjects of reproductive potential must agree to practice effective contraception
from at least 14 days prior to the first dose of study drug through at least 30 days
after their last dose of study drug.
Key Exclusion Criteria:
- History of any clinically significant cardiac, endocrine, GI, hematologic, hepatic,
immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric,
and renal, or other major disease, as determined by the Investigator.
- Treatment with another investigational drug or approved therapy for investigational
use within 30 days (or 5 half-lives, whichever is longer) prior to Day -1.
NOTE: Other protocol definted Inclusion/Exclusion criteria may apply
We found this trial at
2
sites
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