Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 80 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02171208
The ClinicalTrials.gov registry entry for NCT02171208 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which dimethyl fumarate - Reference form is the first listed.
NCT02171208 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.