Skip to main content
OpenTrials
Completed

NCT Number: NCT02171208

A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/Exclusion criteria may apply

Treatment and study plan

dimethyl fumarate - Reference form

Drug

single dose 240 mg

Other names: BG00012 Tecfidera®

dimethyl fumarate - Test form

Drug

single dose 240 mg

Other names: BG00012

Primary outcomes

  1. Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012

    Time frame: Up to 48 hours following each dose administration

  2. Maximum observed concentration (Cmax) of BG00012

    Time frame: Up to 48 hours following each dose administration

Secondary outcomes

  1. The number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to Day 13

  2. Area under the plasma concentration curve from time of dosing to 48 hours

    Time frame: Up to 48 hours following each dose administration

  3. Apparent clearance (CL/F)

    Time frame: Up to 48 hours following each dose administration

  4. Time to peak plasma concentration (Tmax)

    Time frame: Up to 48 hours following each dose administration

  5. Lag time (tlag)

    Time frame: Up to 48 hours following each dose administration

  6. Half-life (t1/2)

    Time frame: Up to 48 hours following each dose administration

  7. Intra-subject coefficient of variation (CV%) of the reference product for area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax)

    Time frame: Up to 48 hours following each dose administration

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2014
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.