In-vivo Bioequivalence Study of Montelukast 5 mg chewable tablets and 10 mg FC. tablets (Faran Shimi, Iran) With Brand Drug (SINGULAIR® 5 mg chewable Tab. & 10 mg FC Tab., MSD Pharma, Germany) in Iranian Healthy Volunteers
Bioequivalence study of 5mg Montelukast Chewable Tablets & 10 mg FC Tablets manufactured by Faran pharmed versus originate brand SINGULAIR® 5 mg Chewable Tablets & 10 mg FC Tablets in healthy volunteers
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct
The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (24h). The interval between these two periods is one week. The candidates were divided into two groups in the first round of the study. the first group receives a test tablet and the second group receives a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin Laboratory in Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: General Health (Liver, Heart, and Kidney); Body Mass Index (18-28 kg/m^2); Informed consent; age (18-55 years old). Exclusion criteria: smoking; history of cardiovascular disease; history of liver and kidney disease; alcohol and drug addiction; history of allergy to
Intervention groups
Intervention group 1: SINGULAIR® 5 mg Chewable Tablets & 10 mg FC Tablets as a reference Intervention group 2: 5mg Montelukast Chewable Tablets & 10 mg FC Tablets as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N104
Registration date:2024-06-16, 1403/03/27
Registration timing:prospective
Last update:2024-06-16, 1403/03/27
Update count:0
Registration date
2024-06-16, 1403/03/27
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
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In-vivo Bioequivalence Study of Montelukast 5 mg chewable tablets and 10 mg FC. tablets (Faran Shimi, Iran) With Brand Drug (SINGULAIR® 5 mg chewable Tab. & 10 mg FC Tab., MSD Pharma, Germany) in Iranian Healthy Volunteers
Public title
In-vivo Bioequivalence Study of Montelukast 5 mg chewable tablets and 10 mg FC. tablets (Faran Shimi, Iran)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney)
Body Mass Index 18-28 kg/m^2
consentAge of 18-55 years old
Informed consent
Exclusion criteria:
Nicotine consumption
history Cardiovascular disease
History Liver and kidney
HistoryAlcohol and opioid addiction
Allergy reactions history to Montelukast
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
28
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. The balls are then removed randomly from the container. The first 12 no.s are considered as (first sequence: faran shimi medicine ) and the second 12 no.s are considered as (first sequence: originator brand recipient). The volunteers don't have any information about taking the test drug or brand drug
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Test and Originator brand's tablets 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. The blinded group in this study is volunteers.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences ethics committe
Street address
Research and technology deputy,3rd floor, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2024-05-20, 1403/02/31
Ethics committee reference number
IR.TBZMED.REC.1403.163
Health conditions studied
1
Description of health condition studied
This study is performed on healthy volunteers and drug concentration in plasma is determined.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
- 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10, 24h after drug administration
Method of measurement
Liquid Chromatography Mass-Mass
Secondary outcomes
1
Description
Time to reach maximum plasma concentration
Timepoint
After intervention
Method of measurement
Time to reach the maximum drug concentration in plasma is recorded.
2
Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time
Intervention groups
1
Description
Intervention group: Intervention group:Single dose, one oral The Reference Drug (SINGULAIR® 5 mg Merch Sharp & Dohme, MSD, Germany). after washout period, the volunteers receive Montelukast 5 mg chewable tablets and 10 mg FC. tablets (Faran Shimi, Iran)
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: Single dose, the volunteers receive Montelukast 5 mg chewable tablets and 10 mg FC. tablets (Faran Shimi, Iran).after washout period, the volunteers The Reference Drug (SINGULAIR® 5 mg Merch Sharp & Dohme, MSD, Germany)