Bioequivalence study of famotidine 40 mg tablets of Ramopharmin pharmaceutical company compared to Famotidine 40 mg of Ratiopharm GmbH in Germany on healthy volunteers.
Bioequivalence study of famotidine 40 mg tablets of Ramopharmin pharmaceutical company compared to Famotidine 40 mg of Ratiopharm GmbH in Germany on healthy volunteers.
Design
The present clinical trial includes the bioequivalence study of famotidine 40 mg tablets of Ramopharmin pharmaceutical company compared to the sample of famotidine 40 mg of Ratiopharm GmbH, Germany, after administration to 24 healthy human volunteers, it is in two intervention groups, cross-over, unblinded and non-randomized.
Settings and conduct
The study is carried out at Nik Azma Pars Alborz company located in Mahdasht Karaj. The blinded cross-over study includes two phases (oral consumption of one 40 mg famotidine tablet per study and 2 times in total) with a one-week washout period on 24 fasting healthy volunteers. Then the obtained blood samples are determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy volunteers; Age between 18 and 55 years; non smoker; Exclusion criteria: candidates with blood pressure less than 90 on 60 mm Hg or higher than 140 on 90 mm Hg.
Intervention groups
The study includes two stages as intervention 1: including oral consumption of famotidine 40 mg tablets of Ramopharmin Pharmaceutical Company of Iran and intervention 2: consumption of famotidine 40 mg tablets of Ratiopharm GmbH of Germany. 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 of famotidine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057495N12
Registration date:2023-12-19, 1402/09/28
Registration timing:registered_while_recruiting
Last update:2023-12-19, 1402/09/28
Update count:0
Registration date
2023-12-19, 1402/09/28
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
2023-12-16, 1402/09/25
Expected recruitment end date
2024-12-15, 1403/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of famotidine 40 mg tablets of Ramopharmin pharmaceutical company compared to Famotidine 40 mg of Ratiopharm GmbH in Germany on healthy volunteers.
Public title
Bioequivalence study of famotidine 40 mg tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteer between 18 and 55 years old.
Body mass index less than 30 kg per square meter.
All candidates must be non-smokers.
Exclusion criteria:
Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg.
Consumption of any drug, alcohol or tobacco within 2 weeks before receiving the drug
Age
From 18 years old to 55 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:
30
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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
2023-12-10, 1402/09/19
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.121
Health conditions studied
1
Description of health condition studied
In this research, no disease is studied.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maximum plasma concentration of famotidine
Timepoint
Before taking the medicine and: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300, 360, 420, 600 and 720 minutes after taking the medicine.
Method of measurement
Liquid chromatography-mass spectrometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: includes the oral consumption of famotidine 40 mg tablets manufactured by Ramopharmin Pharmaceutical Company of Iran on 24 fasting healthy volunteers. 5 ml of blood was taken from the volunteers at time intervals before taking the drug and: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300, 360, 420, 600 and 720 minutes after taking the drug. can be The cross-over study consists of two phases (oral administration of one 40 mg famotidine tablet per study and 2 times in total) with a one-week washout period (when the drug is completely removed from your blood). The plasma concentration of famotidine is determined by liquid chromatography-mass spectrometry.
Category
Other
2
Description
Intervention group 2: includes the oral consumption of famotidine 40 mg tablets of Ratiopharm GmbH, Germany, on 24 fasting healthy volunteers. 5 ml of blood was taken from the volunteers at time intervals before taking the drug and: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300, 360, 420, 600 and 720 minutes after taking the drug. can be The cross-over study consists of two phases (oral administration of one 40 mg famotidine tablet per study and 2 times in total) with a one-week washout period (when the drug is completely removed from your blood). The plasma concentration of famotidine is determined by liquid chromatography-mass spectrometry.
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
Ramopharmin Pharmaceutical Company
Full name of responsible person
Afsane Sabeti
Street address
In front of Azadi settlement, Valiasr St., Mina Glassmaking St.,Kilometer 4 of Karaj Special Road
City
Tehran
Province
Tehran
Postal code
1398834111
Phone
+98 21 4453 6020
Email
info@ramopharmin.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ramopharmin Pharmaceutical Company
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
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
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
Person responsible for updating data
Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Azadegan Squar, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available