Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012

A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01420458

Enrollment

Registered

2011-08-19

Start date

2011-08-31

Completion date

2011-09-30

Last updated

2011-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

bioequivalence

Brief summary

This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.

Detailed description

This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..

Interventions

DRUGExperimental

Bioequivalence of two drug formulations

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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). * Known history of or positive test result for Human Immunodeficiency Virus (HIV) * History of severe allergic or anaphylactic reactions. * 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.

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration curve as a measure of PK.	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

Secondary

Measure	Time frame
The number of AEs in participants as a measure of safety and tolerability.	Participants will be followed during the time of study - an estimated four days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026