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Completed

NCT Number: NCT01632449

Study in Healthy Volunteers to Establish the Bioequivalence of 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Minneapolis, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

test product

Drug

Dimethyl Fumarate (BG00012)

Reference Product

Drug

Dimethyl Fumarate (BG00012)

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. The number of AEs in participants as a measure of safety and tolerability.

    Time frame: Participants will be followed during the study, 4 days.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 3, 2012
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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