Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.

A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.

This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Test product; Drug: Reference product

Detailed Description

This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must give written and informed consent and any authorizations required by local law.
• Males and females 18 - 55 years old inclusive at time of consent.
• Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

• History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.
• Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
• Current enrollment in any other drug, biologic, or device study.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Test product	Drug: Test product; Dimethyl Fumarate (BG00012); Drug: Reference product; Dimethyl Fumarate (BG00012)
Experimental: 2; Reference product	Drug: Test product; Dimethyl Fumarate (BG00012); Drug: Reference product; Dimethyl Fumarate (BG00012)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK - Area under the plasma concentration curve.	Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
Peak plasma concentration as a measure of PK.	Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of AEs in participants as a measure of safety and tolerability.	Participants will be followed during the study, 4 days.

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: July 2, 2012
• First Posted (Estimate): July 3, 2012

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: bioequivalence
• Other Study ID Numbers: 109HV109