In- Vivo Bioequivalence study of Fampridine 10 mg Pharan shimi with brand drugs FAMPYRA 10mg Biogen Idec, UK
Design
Single dose of Fampridine 10 mg Pharan shimi Pharmaceutical Company.
Settings and conduct
This study will be conducted in two-way, cross-over and fasting, and on two sets of healthy volunteers. The study will be conducted in two periods of twenty-four hours.The interval between these two periods, which is called the wash-out time, is determined by the half-life of the drug plasma, which according to scientific sources should be at least 5 to 7 half-life of the drug in the case of the drug under study. The plan will take a week to clean up the drug, given the biological half-life of the drugs in the drug form.In the first round, candidates are divided into two groups, and the first group receives a test tablet and the second group receives a similar tablet. Blood samples will taken by the volunteer by the technician immediately after taking the drug, and the preparation steps of the samples, including plasma separation and drug extraction, are performed to analyze the amount of drug
Participants/Inclusion and exclusion criteria
In this study، 24 participants of both sexes will be selected. The inclusion criteria is: general health, age between 18 to 60, body mass index between 18 to 30. Exclusion criteria is: non-pregnant and non- smokers
Intervention groups
Intervention group Single dose Fampridine 10 mg Pharan shimi Pharmaceutical Company and Control group Single dose of TRAJENTA tablet with brand drugs FAMPYRA 10mg Biogen Idec, UK.
Main outcome variables
Determination of blood drug concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N19
Registration date:2021-01-10, 1399/10/21
Registration timing:prospective
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Javad Shokri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3661 4125
Email address
shokri.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-07-27, 1400/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pharmacokinetic assessments of Fampridine tablet 10mg extended release in comparison with brand drugs FAMPYRA
Public title
In-vivo Bioequivalence Test Fampridine tablet with brand drug FAMPYRA Made by Biogen Idec, UK.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health
Body Mass Index (BMI) between 18-28
Informed consent
Age between 18-60
Both male and female
Exclusion criteria:
Smoking
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Age
From 18 years old to 60 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation law will be used for randomization of volunteers in this study. By this method, sequences 1(subjects no: 1-12) and sequences 2 (subjects no: 13-12) will be selected by using a simple paper lottery. the first and second 12 persons will be considered as sequence 1 (Group A) and sequence 2 (Group B) respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
Candidates are not aware of the test drug or brand name. In a one-blind study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Fampridine and FAMPYRA are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Tabriz University of Medical Sciences
Street address
Third floor of TUMS (Tabriz University of Medical Sciences) central building, Dneshgah St. Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-12-29, 1399/10/09
Ethics committee reference number
IR.TBZMED.REC.1399.894
Health conditions studied
1
Description of health condition studied
The aim of this study is evaluation of bioequivalence of test and reference drugs and the study will one by healthy volunteers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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 times after drug administration and the concentration of lacosamide in blood samples was measured by liquid chromatography with mass spectroscopy detector.
Category
Treatment - Drugs
2
Description
Control group: Control group received one test drug table (FAMPYRA 10mg Biogen Idec, UK.). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of lacosamide in blood samples was measured by liquid chromatography with mass spectroscopy detector.