ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01632449
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Test product Drug: Reference product Phase 1

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  1. PK - Area under the plasma concentration curve. [ Time Frame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours ]
  2. Peak plasma concentration as a measure of PK. [ Time Frame: 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 :
  1. The number of AEs in participants as a measure of safety and tolerability. [ Time Frame: Participants will be followed during the study, 4 days. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632449


Locations
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01632449     History of Changes
Other Study ID Numbers: 109HV109
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by Biogen:
bioequivalence

Additional relevant MeSH terms:
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs