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

June 21, 2012
May 30, 2013
July 2012
September 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • PK - Area under the plasma concentration curve. [ Time Frame: Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs ] [ 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. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01632449 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Healthy Volunteers
  • Drug: Test product
    Dimethyl Fumarate (BG00012)
  • Drug: Reference product
    Dimethyl Fumarate (BG00012)
  • Experimental: 1
    Test product
    Interventions:
    • Drug: Test product
    • Drug: Reference product
  • Experimental: 2
    Reference product
    Interventions:
    • Drug: Test product
    • Drug: Reference product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01632449
109HV109
No
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP