In-vivo Bioequivalence Test of Dimethyl fumarate Capsules with brand drug (TECFIDERA® 240 mg, Biogen, Germany)

In- Vivo Bioequivalence Study of Dimethyl fumarate 240 mg Enteric-coated test (DIPHOSEL® 240 mg EC. Caps. ?Abidi, Iran) with brand drug (TECFIDERA® 240 mg, Biogen, Germany) in Iranian healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N43

Enrollment

Registered

2021-10-30

Start date

2021-11-03

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence Study.

Interventions

Intervention 1: Intervention group: they will receive one test drug (Dimethyl fumarate 240 mg Entric-coated Capsules? ABIDI Pharma. Iran). Blood samples will be taken during 72 hours at the mentio

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body mass index between18-28 Informed consent Being at the age of 18-60 years old

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver or kidney disease Pregnancy Alcohol & Drug addiction History of hypersensitivity

Design outcomes

Primary

Measure	Time frame
Plasma drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography tandem mass spectroscopy.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

Shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026