Protocol summary

Study aim
This study will be performed to compare the pharmacokinetics and invivo parameters of Domperidone 10 mg F.C. Tablet formulation as a test product with Motilium® tablet formulation as a reference product and to evaluate the biocompatibility of these two formulations.
Design
Randomized, single-dose, crossover comparative bioequivalence study of Domperidone 10 mg F.C. Tablet of Actover. and Janssen. in 24 healthy male under fasting.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Farabi Clinic (Eslamshahr, Tehran). 2 dosing periods will be separated by a 7-day washout period.
Participants/Inclusion and exclusion criteria
Healthy subjects should be between 18 – 45 years of age and their Body Mass Index (BMI) should be in the normal range according to the accepted average values between 18.5 and 30 (inclusive), calculated as kg/m2 Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, and laboratory evaluations.
Intervention groups
Intervention group (test): Domperidone 10 mg F.C. Tablet, produced by َActover is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product.Intervention group (Reference): Motilium® capsule, produced by Janssen is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Main outcome variables
Peak Plasma Concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180620040164N12
Registration date: 2021-10-22, 1400/07/30
Registration timing: retrospective

Last update: 2021-10-22, 1400/07/30
Update count: 0
Registration date
2021-10-22, 1400/07/30
Registrant information
Name
Behzad Montaha Sangari
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-12, 1399/03/23
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Domperidone 10 mg F.C. Tablet of ACTOVERCO and Janssen Inc. in 24 healthy male under fasting
Public title
Bioequivalence study of Domperidone 10 mg F.C. Tablet in 24 healthy male under fasting conditions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects should be between 18 – 45 years of age and their Body Mass Index (BMI) should be in the normal range according to the accepted average values between 18.5 and 30 (inclusive), calculated as kg/m2 Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, and laboratory evaluations. Have a ECG and normal vital signs. Subjects who agree with the patient consent form.
Exclusion criteria:
History of allergy or iosyncrasy to domperidone or any of the inactive components of the formulation. If you have or have a history of arrhythmia, including tachycardia or ventricular fibrillation, increased QT interval, bradycardia, or heart failure. Identify electrolyte disturbances and water loss due to diarrhea, vomiting or other causes 24 hours before the study. Bleeding or obstruction of the gastrointestinal tract during the last 6 weeks. In case of acute or chronic diseases related to the cardiovascular, respiratory, gastrointestinal, endocrine, blood and kidney or liver failure systems. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who have used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during the study period. History of alcohol or drug abuse within 5 years before the start of the study. Heavy drinker of caffeine, grapefruit juice, or caffeinated drinks or who are on a special diet (such as vegetarians) or do exertional physical activity. A history of difficulty with donating blood or donation of more than 450 ml blood within 60 days prior to the start of the study.
Age
From 18 years old to 45 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization schedule will be generated with the BEAR statistical software (Release V2.7.7). Each volunteer will be randomly assigned to one of the 2 different sequence of treatments according to the order of entering the study which will be allocated after screening.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.268

Health conditions studied

1

Description of health condition studied
Bioequivalence investigation of the generic Actover.Domperidone 10 mg F.C. Tablet with brand Motilium® Janssen capsule.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Peak Plasma Concentration (Cmax)
Timepoint
During 2 months after intervention
Method of measurement
using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)

Secondary outcomes

1

Description
AUC (Area Under the Concentration-Time Curve)
Timepoint
During 2 months after intervention
Method of measurement
using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)

Intervention groups

1

Description
Intervention group: Intervention group: (test): Domperidone 10 mg F.C. Tablet, produced by Actover is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group: Domperidone 10 mg F.C. Tablet, produced by Janssen is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hakim Farabi Clinic
Full name of responsible person
Ebrahim Siahpoosh
Street address
No. 57, Shemshad alley, Sallor city
City
Tehran
Province
Tehran
Postal code
4635314588
Phone
+98 21 9253 5647
Email
mina.hasanabadi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
ACtover Pharmaceutical Co.
Full name of responsible person
Nahaleh Naraghi
Street address
58 plaque, 8th St., Gisha
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4162 7000
Email
info@actoverco.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ACtover Pharmaceutical Co.
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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Noor Research & Development Institute
Full name of responsible person
Ali Aghaei
Position
Master
Latest degree
Master
Other areas of specialty/work
pharmacy
Street address
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Seyed Mohsen Foroutan
Position
Principal investigator
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir

Person responsible for updating data

Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
علی آقایی
Position
Master
Latest degree
Ph.D.
Other areas of specialty/work
pharmacy
Street address
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It's not specified yet.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
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