Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jul 2012
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedFirst Posted
Study publicly available on registry
July 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedMay 31, 2013
May 1, 2013
2 months
June 21, 2012
May 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
The number of AEs in participants as a measure of safety and tolerability.
Participants will be followed during the study, 4 days.
Study Arms (2)
1
EXPERIMENTALTest product
2
EXPERIMENTALReference product
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (1)
Research Site
Minneapolis, Minnesota, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
July 3, 2012
Study Start
July 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
May 31, 2013
Record last verified: 2013-05