Healthy
Conditions
Brief summary
The primary objective of this study is to establish the bioequivalence of the test product (BG00012 \[dimethyl fumarate\] 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 referenced product for both area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax).
Interventions
DRUGdimethyl fumarate - Reference form
single dose 240 mg
DRUGdimethyl fumarate - Test form
single dose 240 mg
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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 defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012 | Up to 48 hours following each dose administration |
| Maximum observed concentration (Cmax) of BG00012 | Up to 48 hours following each dose administration |
Secondary
| Measure | Time frame |
|---|---|
| Apparent clearance (CL/F) | Up to 48 hours following each dose administration |
| Time to peak plasma concentration (Tmax) | Up to 48 hours following each dose administration |
| The number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to Day 13 |
| Half-life (t1/2) | Up to 48 hours following each dose administration |
| Intra-subject coefficient of variation (CV%) of the reference product for area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax) | Up to 48 hours following each dose administration |
| Lag time (tlag) | Up to 48 hours following each dose administration |
| Area under the plasma concentration curve from time of dosing to 48 hours | Up to 48 hours following each dose administration |
Countries
United States
Outcome results
None listed