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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Test product; Drug: Reference product

• Registration Number: NCT01632449
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-06-21
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-02
• Study First Posted: 2012-07-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Test product	Test product
1	Reference product	Test product
2	Test product	Reference product
2	Reference product	Reference product

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Minneapolis, Minnesota, United States