MedTrace Logo

A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

NCT01215084 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-07-09

No results posted yet for this study

Summary

The primary objective of the study is to determine the Pharmacokinetic (PK) and safety profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The secondary objective of this study is to compare the PK and safety profiles of fampridine-PR 10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

BIIB041 (Fampridine-PR)

A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants

Sponsors & Collaborators

  • Acorda Therapeutics

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Australia
  • Hong Kong

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215084 on ClinicalTrials.gov