Protocol summary

Study aim
Bioequivalence study of Montelukast 4 mg granule manufactured by Actover pharmaceutical company
Design
Clinical trials of 24 volunteers
Settings and conduct
After selecting the volunteers, Montelukast drug manufactured by Actover and Merck will be prescribed to them orally in two doses with an interval of 7 days. For example, if in the first period, the volunteer received the drug manufactured by Actover, in the next turn, the volunteer will receive the drug manufactured byMerck . Each time the amount of 6 cc of blood before drug administration and at times of 0، 1، 5/1، 2، 5/2، 3، 5/3، 4، 5/4، 5، 6، 7، 8، 10، 12 , 24 hour after the medication is prescribed. Samples were collected in Anticoagulant tube collection tubes. The tubes were centrifuged and plasma samples were stored at -80 ℃ . Finally, the amount of drug in each sample is determined by Lc Mass Mass equipment. equipment.
Participants/Inclusion and exclusion criteria
Healthy volunteers, no history of diseases affecting the pharmacokinetic processes of the drug, no chronic or acute use of any drug at least 1 week before starting the study
Intervention groups
Volunteers will divided in two groups: On the first week, group one will receive Montelukast manufactured by Actover pharmaceutical company and group number two will receive Montelukast manufactured by Merck pharmaceutical company . On the second week, group number one will receive Montelukast manufactured by Merck pharmaceutical company and group number two will receive Montelukast manufactured by Actover pharmaceutical company (cross over)
Main outcome variables
Maximum plasma concentration; area under the curve; the time take to reach maximum plasma concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200625047913N17
Registration date: 2024-07-14, 1403/04/24
Registration timing: prospective

Last update: 2024-07-14, 1403/04/24
Update count: 0
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
Tayebeh Ghari
Name of organization / entity
Hezareh Sevom Futuristic Pharmacist Company
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 2343
Email address
info@hezareh-co.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-20, 1403/06/30
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence evaluation of Montelukast 4 mg granule of Actover Pharmaceutical company
Public title
Bioequivalence evaluation of Montelukast 4 mg granule of Actover Pharmaceutical company
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 45 years old Sex: Males and/or non-pregnant, non-lactating females BMI: 18.5 to 24.9 weight in kg/(height in meter) Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent A physical examination with no clinically significant finding and laboratory normal tests Do not take any chronic or acute medication for at least 1 week before the start of the study No history of diseases affecting the pharmacokinetic processes of the drug
Exclusion criteria:
History of allergic responses to Montelukast or other related drugs, or any of its formulation ingredients Have significant diseases (which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system) or clinically significant abnormal findings during screening History or presence of bronchial asthma Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period History or evidence of drug dependence or of alcoholism or of moderate alcohol use History of difficulty with donating blood or difficulty in accessibility of veins Volunteers who have received a known investigational drug within five elimination half life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the initial dose of study drug, whichever is greater Found positive in urine test for drugs of abuse done before check-in of period History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption
Age
From 18 years old to 45 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Each volunteer, without being informed, randomly takes the test or reference drug for one week and does the opposite in the next week. Volunteers do not know which medication they will receive each week. Randomization is done in a simple way. Each person is given a number. Then, for each test and reference number, it is considered and written on paper. All the notes are put into the bag and they are taken out one by one until the last number.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each volunteer, without being informed, randomly takes the test or reference drug for one week and does the opposite in the next week. Volunteers do not know which medication they will receive each week. Randomization is done in a simple way. Each person is given a number. Then, for each test and reference number, it is considered and written on paper. All the notes are put into the bag and they are taken out one by one until the last number.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Faculty of Paramedicine, 2nd floor, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-06-30, 1403/04/10
Ethics committee reference number
IR.IUMS.REC.1403.287

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Plasma concentration
Timepoint
0، 1، 5/1، 2، 5/2، 3، 5/3، 4، 5/4، 5، 6، 7، 8، 10، 12 , 24 hr
Method of measurement
lc ms ms

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Montelukast 4 mg granule made by Actover pharmaceutical company from Iran will prescribe in the first week at fast condition and blood samples will draw in determined intervals.
Category
N/A

2

Description
Control group: Montelukast 4 mg granule made by Merck pharmaceutical company from Germany will prescribe in the first week at fast condition and blood samples will draw in determined intervals.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hezareh Sevom Futuristic Pharmacist Company
Full name of responsible person
Tayebeh Ghari
Street address
Unit 4, No. 81, Babak Bahrami st, After Zafar st, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1968655815
Phone
+98 21 8865 2343
Fax
+98 21 8820 8678
Email
info@hezareh-co.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hezareh Sevom Futuristic Pharmacist
Full name of responsible person
Tayebeh Ghari
Street address
Unit 4, No 81, Babak Bahrami st, After Zafar st, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1968655815
Phone
+98 21 8865 2343
Email
info@hezareh-co.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hezareh Sevom Futuristic Pharmacist
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Alborze University of Medical Sciences, School of Pharmacy
Full name of responsible person
Faranak Salmannejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alborze School of pharmacy, near Bahonar Hospital, Vali-e-asr st, Shora Blv, Karaj.
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Fax
+98 26 3256 7176
Email
salmannejad.f@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborze University of Medical Sciencesو School of Pharmacy
Full name of responsible person
Faranak Salmannejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alborze School of pharmacy, near Bahonar Hospital, Vali-e-asr st, Shora Blv,Karaj.
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Email
salmannejad.f@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Alborze University of Medical Sciences, School of Pharmacy
Full name of responsible person
Faranak Salmannejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alborze School of pharmacy, near Bahonar Hospital, Vali-e-asr st, Shora lv, Karaj.
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Email
salmannejad.f@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
from 2024
To whom data/document is available
People working in industry and academia
Under which criteria data/document could be used
People working in industry and academia
From where data/document is obtainable
Sending email to info@hezareh-co.com - Sending fax to 00982188208678 - Calling to 00982188652343 - Responsible person: Tayebeh Ghari
What processes are involved for a request to access data/document
Sending email to info@hezareh-co.com/ request evaluation/sending data
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