Clinical trials: Tecfidera
Relapsing Remitting Multiple Sclerosis
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve…
- Trial name
- NCT04570670
- Testing
- monomethyl fumarate 190 mg, dimethyl fumarate 240 mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Healthy Volunteers
Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.
- Trial name
- NCT01420458
- Testing
- Experimental
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
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…
- Trial name
- NCT02171208
- Testing
- dimethyl fumarate - Reference form, dimethyl fumarate - Test form
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
The primary objective of the study is to determine the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in healthy volunteers receiving TECFIDERA™ (dimethyl…
- Trial name
- NCT01915901
- Testing
- bismuth subsalicylate (Pepto-Bismol®), dimethyl fumarate (DMF)
- Where
- 3 sites in United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.
- Trial name
- 109HV108 (NCT01453426)
- Testing
- BG00012 Dose 1, BG00012 Dose 2
- Where
- 2 sites in Australia, China
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Biogen
Psoriasis
Study of the Effects of the Organism on Monomethyl Fumarate (MMF) After the Administration of LAS41008
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…
- Trial name
- LAS41008 (NCT02955693)
- Testing
- LAS41008 120 mg / Fumaderm® 120 mg
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Almirall, S.A.
Multiple Sclerosis
Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate).
- Trial name
- NCT04022473
- Testing
- Bafiertam, Tecfidera
- Where
- United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Healthy Volunteers
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.
- Trial name
- NCT01632449
- Testing
- Test product, Reference product
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single…
- Trial name
- NCT01069913
- Testing
- BG00012
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
BG00012 Regional Absorption Study
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying…
- Trial name
- NCT01924832
- Testing
- dimethyl fumarate
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Alternate Dosing Regimens of BG00012 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo
- Trial name
- 109HV106 (NCT01281111)
- Testing
- Dimethyl Fumarate (BG00012), Aspirin
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate
The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events…
- Trial name
- NCT01568112
- Testing
- BG00012 (dimethyl fumarate), ASA
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Biogen