In vivo bioequivalence study of Diroximel fumarate 231 mg EC .Capsules of zist daru danesh

In vivo bioequivalence study of Diroximel fumarate 231 mg EC .Capsules of zist daru danesh as Test Drug in compared with the reference Drug in Iranian Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N142

Enrollment

Registered

2025-05-24

Start date

2025-07-23

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

This study is performed on healthy volunteers..

Interventions

Intervention 1: Control group: Single-dose of Diroximel fumarate 231 mg EC .Capsules of of zist daru danesh , in the first period. Intervention 2: Control group: Single-dose of the The Reference Drug

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-30) Informed consent Age(18-55)

Exclusion criteria

Exclusion criteria: Smoking history of cardiovascular disease history of liver & kidney disease Alcohol & Drug addiction Hypersensitivity to the drug Pregnancy

Design outcomes

Primary

Measure	Time frame
The concentration of the drug in blood. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 5.5, 6 , 8, 10, 12h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.	—

Secondary

Measure	Time frame
Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3661 4125

Outcome results

None listed

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