---
title: Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
nct_id: NCT01632449
overall_status: COMPLETED
phase: PHASE1
sponsor: Biogen
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01632449.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01632449"
ct_last_update_post_date: 2013-05-31
last_seen_at: "2026-05-12T06:43:34.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.

**Official Title:** A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.

**NCT ID:** [NCT01632449](https://clinicaltrials.gov/study/NCT01632449)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Biogen
- **Conditions:** Healthy Volunteers
- **Start Date:** 2012-07
- **Completion Date:** 2012-09
- **CT.gov Last Update:** 2013-05-31

## 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.

## Detailed Description

This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **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).
* 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.
```

## Arms

- **1** (EXPERIMENTAL) — Test product
- **2** (EXPERIMENTAL) — Reference product

## Interventions

- **Test product** (DRUG) — Dimethyl Fumarate (BG00012)
- **Reference product** (DRUG) — Dimethyl Fumarate (BG00012)

## Primary Outcomes

- **PK - Area under the plasma concentration curve.** _(time frame: 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.** _(time frame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours)_

## Secondary Outcomes

- **The number of AEs in participants as a measure of safety and tolerability.** _(time frame: Participants will be followed during the study, 4 days.)_

## Locations (1)

- Research Site, Minneapolis, Minnesota, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.research site|minneapolis|minnesota|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01632449.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01632449*  
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