Bioequivalence study of Dimethyl Fumarate 240mg capsule of Nanoalvand Co., IRAN

A randomized, open label, single dose, crossover, bioequivalence study of Dimethyl Fumarate 240mg capsule of Nanoalvand Co., IRAN in comparison of Tecfidera 240mg capsule of Biogen in 24 healthy adult subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190706044111N22

Enrollment

Registered

2021-07-03

Start date

2021-07-23

Completion date

Unknown

Last updated

2021-07-12

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

Conditions

Multiple Sclerosis (MS). Multiple Sclerosis

Interventions

Intervention 1: Intervention group: Dimethyl Fumarate 240mg capsule, produced by Nanoalvand Co., (IRAN), single dose. Intervention 2: Control group: Tecfidera one 240mg capsule, produced by Biogen com

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: - Aged between 18 - 50 years - Body weight between 50 – 100 kg - Having good health on the basis of medical history and physical & clinical examination - Understand the procedures and give written informed consent

Exclusion criteria

Exclusion criteria: Subject had undergone surgery of the gastro-intestinal tract treatment. Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.

Design outcomes

Primary

Measure	Time frame
Monomethyl Fumarate (MMF). Timepoint: at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0 & 10.0 hr. after dosing. Method of measurement: Using High Performance Liquid Chromatography wit MS detector (HPLC/MS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLadan Tayebi

Pars Biopharmacy Research Co.

l.tayebi@parsbiopharmacy.com+98 21 8895 6061

Outcome results

None listed

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