In-vivo Bioequivalence Test Fampridine tablet with brand drug FAMPYRA Made by Biogen Idec, UK.

Pharmacokinetic assessments of Fampridine tablet 10mg extended release in comparison with brand drugs FAMPYRA

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N19

Enrollment

Registered

2021-01-10

Start date

2021-03-05

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

The aim of this study is evaluation of bioequivalence of test and reference drugs and the study will one by healthy volunteers.

Interventions

Intervention 1: Intervention group: Intervention group received one test drug table (Fampridine 10 mg Pharan shimi Company). Blood samples were taken from the volunteers for 72 hours at the mentioned

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General health Body Mass Index (BMI) between 18-28 Informed consent Age between 18-60 Both male and female

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Blood concentration of the drug. 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 received tablet. Method of measurement: Liquid Chromatography with tandem mass spectroscopy detector.	—

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