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: January 17, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	June 21, 2012
Last Updated Date	January 17, 2013
Start Date ^ICMJE	July 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 17, 2013)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: July 2, 2012)	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 ]
Change History	Complete list of historical versions of study NCT01632449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 2, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
Official Title ^ICMJE	A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.
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.
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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	Healthy Volunteers
Intervention ^ICMJE	Drug: Test product Dimethyl Fumarate (BG00012) Drug: Reference product Dimethyl Fumarate (BG00012)
Study Arm (s)	Experimental: 1 Test product Interventions: Drug: Test product Drug: Reference product Experimental: 2 Reference product Interventions: Drug: Test product Drug: Reference product
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	80
Completion Date	October 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01632449
Other Study ID Numbers ^ICMJE	109HV109
Has Data Monitoring Committee	No
Responsible Party	Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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