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NCT02171208 · ClinicalTrials.gov registry record · Phase 1
A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT02171208: Completed Phase 1 study, sponsored by Biogen.
NCT02171208 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02171208, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The primary objective of this study is to establish the bioequivalence of the test product (BG00012 \[dimethyl fumarate\] supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers. The secondary objectives of this study are to determine the safety and tolerability of the test product compared to the reference product, to estimate PK parameters of the test product and the reference product, and to estimate the intra-subject coefficient of variation (CV%) of the referenced product for both area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax).
Interventions
- DRUG dimethyl fumarate - Reference form
- DRUG dimethyl fumarate - Test form
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-06 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT02171208 record still lists
NCT02171208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which dimethyl fumarate - Reference form is the first listed.
NCT02171208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02171208 about?
NCT02171208 is a clinical study titled "A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers". The primary objective of this study is to establish the bioequivalence of the test product (BG00012 \[dimethyl fumarate\] supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers. The secondary objectiv...
What is the current status of trial NCT02171208?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2014-06. Estimated completion is 2014-07.
What interventions are being tested in trial NCT02171208?
The interventions under investigation include: dimethyl fumarate - Reference form (DRUG), dimethyl fumarate - Test form (DRUG).
Who is sponsoring clinical trial NCT02171208?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02171208's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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