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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632449
• Other study ID #: 109HV109
• Status: Completed
• Phase: Phase 1
• First received: June 21, 2012
• Last updated: May 30, 2013
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Test product
Dimethyl Fumarate (BG00012)
• Reference product
Dimethyl Fumarate (BG00012)

Locations

Country	Name	City	State
United States	Research Site	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	The number of AEs in participants as a measure of safety and tolerability.		Participants will be followed during the study, 4 days.	Yes