Multiple Sclerosis (MS). Multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group: Single oral dose of ?Fampiridine 10mg tablet of AlborzDarou Pharm Co. Intervention 2: Control group: Single oral dose of Fampyra 10mg tablet of Biogen.
Sponsors
Alborzdarou Pharm. Co.
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: - Aged between 20 - 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 showed clinically relevant deviations from normal in physical examination. Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment. 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. Subject had a history of allergic to drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of famperidine. Timepoint: 0 (before dosing), 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0 & 24.0 hr. after dosing. Method of measurement: HPLC/MS. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactLadan Tayebi
Pars Biopharmacy Research Co.
Outcome results
None listed