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Study of the Effects of the Organism on Monomethyl Fumarate (MMF) After the Administration of LAS41008

NCT02955693 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-12-22

No results posted yet for this study

Summary

The purpose of this study is to determine how the organism affects MMF (metabolite of dimethyl fumarate \[DMF\]) after single oral dose administration of LAS41008 120 mg gastroresistant tablet and Fumaderm® 120 mg gastro-resistant tablet under fasting and fed conditions. The study also aims to assess the safety of the study treatments.

Conditions

Interventions

DRUG

LAS41008 120 mg / Fumaderm® 120 mg

Single dose of LAS41008 120 mg or Fumaderm® 120 mg in each Period

Sponsors & Collaborators

  • Almirall, S.A.

    lead INDUSTRY

Principal Investigators

  • Wolf-Godehard Ocker, MD · Almirall Hermal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02955693 on ClinicalTrials.gov