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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01632449
First received: June 21, 2012
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Test product
Drug: Reference product
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of AEs in participants as a measure of safety and tolerability. [ Time Frame: Participants will be followed during the study, 4 days. ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632449

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

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01632449     History of Changes
Other Study ID Numbers: 109HV109
Study First Received: June 21, 2012
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
bioequivalence

ClinicalTrials.gov processed this record on August 01, 2014