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NCT01632449 · ClinicalTrials.gov registry record · Phase 1
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
A Phase 1 study of Healthy Volunteers, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT01632449 is a Phase 1 study of Healthy Volunteers that has completed, run by Biogen. The registered enrollment target is 80 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01632449, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Test product
- DRUG Reference product
Study Locations (1)
Minnesota
- Research Site - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2012-07 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01632449
The ClinicalTrials.gov registry entry for NCT01632449 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, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (83% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Test product is the first listed.
NCT01632449 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01632449 about?
NCT01632449 is a clinical study titled "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.
What is the current status of trial NCT01632449?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2012-07. Estimated completion is 2012-09.
What conditions does trial NCT01632449 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01632449?
The interventions under investigation include: Test product (DRUG), Reference product (DRUG).
Who is sponsoring clinical trial NCT01632449?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01632449 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.