Bioequivalence study of domperidone suspension 1 mg/ml of Sina pishgam Darou Novin pharmaceutical company compared to domperidone 1 mg/ml sample of JANSSEN CILAG company of Belgium on healthy volunteers
Bioequivalence study of domperidone suspension 1 mg/ml of Sina pishgam Darou Novin pharmaceutical company compared to domperidone 1 mg/ml sample of JANSSEN CILAG company in Belgium on healthy volunteers
Design
The current clinical trial includes the study of bioequivalence of Domperidone 1 mg/ml suspension product of Sina pishgam Darou Novin Pharmaceutical Company compared to Domperidone 1 mg/ml sample of JANSSEN CILAG Company, Belgium, after administration to 24 healthy human volunteers, in two intervention groups, in a cross-over manner. , is not blinded and non-randomized.
Settings and conduct
The study is carried out at Nik Azma Pars Alborz Company, located in Mahdasht Karaj, Imam Khomeini Blvd., Azadegan Square, No. 419. The blinded cross-over study includes two stages (oral consumption of 20 ml of domperidone suspension 1 mg/ml in each study and 2 times in total) with a one-week washout period on 24 fasting healthy volunteers. Blood samples are taken from volunteers at certain intervals of drug consumption, and then the amount of domperidone in plasma is determined by liquid chromatography-fluorescence.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy volunteers between the ages of 18 and 50 should be non-smokers. Exclusion criteria: volunteers with blood pressure less than 90 over 60 mm Hg or higher than 140 over 90 mm Hg.
Intervention groups
The study includes two stages as intervention 1: including oral consumption of domperidone suspension 1 mg/ml manufactured by Sina pishgam Darou Novin pharmaceutical company in Iran and intervention 2: oral consumption of domperidone suspension 1 mg/ml manufactured by JANSSEN CILAG company in Belgium. This study will be repeated on fasting volunteers in a cross-sectional manner with an interval of one week.
Main outcome variables
Maximum plasma concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057495N7
Registration date:2023-07-03, 1402/04/12
Registration timing:registered_while_recruiting
Last update:2023-07-03, 1402/04/12
Update count:0
Registration date
2023-07-03, 1402/04/12
Registrant information
Name
Monireh Jalalipour
Name of organization / entity
Nikazma Pars Alborz company
Country
Iran (Islamic Republic of)
Phone
+98 26 3731 8748
Email address
info@naplab.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of domperidone suspension 1 mg/ml of Sina pishgam Darou Novin pharmaceutical company compared to domperidone 1 mg/ml sample of JANSSEN CILAG company of Belgium on healthy volunteers
Public title
Bioequivalence study of domperidone suspension 1 mg/ml
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteers aged between 18 and 50 years
All candidates must be non-smokers
Body mass index less than 30 kg per square meter
Exclusion criteria:
Blood pressure less than 90 over 60 mm Hg or more than 140 over 90 mm Hg
Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug
Age
From 18 years old to 50 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
28
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Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences
Street address
Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Tehran University of Medical Sciences, Porsina Street
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.049
Health conditions studied
1
Description of health condition studied
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ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maximum plasma concentration of domperidone
Timepoint
Before taking the drug and: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours after taking the drug
Method of measurement
Liquid Chromatography - Fluorescence
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: includes oral administration of Domperidone suspension 1 mg/ml manufactured by Sina pishgam Darou Novin Pharmaceutical Company of Iran on 24 healthy fasting volunteers. 5 ml of blood at time intervals before starting the drug and: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 It is taken from the volunteers one hour after taking the medicine. The cross-over study consists of two phases (oral administration of 20 ml of domperidone suspension 1 mg/ml per study and 2 times in total) with a one-week washout period (when the drug is completely removed from your blood). . Domperidone plasma concentration is determined by liquid chromatography-fluorescence method. The analysis of the results will be based on ANOVA and t-test statistical methods.
Category
Other
2
Description
Intervention group 2: includes the oral use of domperidone suspension 1 mg/ml made by JANSSEN CILAG company in Belgium on 24 fasting healthy volunteers. 5 ml of blood at time intervals before starting the drug and: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 It is taken from the volunteers one hour after taking the medicine. The cross-over study consists of two phases (oral administration of 20 ml of domperidone suspension 1 mg/ml per study and 2 times in total) with a one-week washout period (when the drug is completely removed from your blood). . Domperidone plasma concentration is determined by liquid chromatography-fluorescence method. The analysis of the results will be based on ANOVA and t-test statistical methods.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nik Azma Pars Alborz Laboratory
Full name of responsible person
Monireh Jalalipour
Street address
No. 419, Azadegan Square, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sina Pishgam Darou Novin Pharmaceutical Company
Full name of responsible person
Zeynab Khansefid
Street address
Sina Building, No. 28, Fourth Alley, North Kargar St.
City
Tehran
Province
Tehran
Postal code
1413694163
Phone
+98 21 8863 0176
Email
info@sinapishgamdarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?