Bioequivalence study of Dimethyl fumarate capsule manufactured by Zistdaru danesh company (Teczifuma 240mg) in Iranian healthy volunteers

Bioequivalence study and evaluation of pharmacokinetic parameters of Dimethyl fumarate medicine manufactured by Zistdaru danesh company (Teczifuma 240) versus Tecfidera 240 manufactured by Biogen Company (originator brand) in healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200623047902N1

Enrollment

Registered

2020-06-26

Start date

2020-06-30

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Dimethyl Fumarate capsule of test and reference in healthy volunteers..

Interventions

Intervention 1: Intervention Group 1: Volunteers take Teczifuma capsule drug, which is manufactured by Zistdaru danesh Company and contains 240 mg of dimethyl fumarate,as a test product, as a single o

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart and Kidney), Body Mass Index (18-28), Conscious Consciousness, Age (18-60)

Exclusion criteria

Exclusion criteria: Smoking, history of cardiovascular disease, history of liver and kidney disease, pregnancy, alcohol and drug addiction, history of drug allergy

Design outcomes

Primary

Measure	Time frame
Determination of concentration of active form of drug in bood. Timepoint: After taking blood sample. Method of measurement: HPLC-MASS MASS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Zistdaru danesh Co.

ghasemian@zistdaru.ir+98 21 6696 5196

Outcome results

None listed

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