In-vivo Bioequivalence Study of Ranolazine 500 mg extended-release tablets (Arang Pharma, Iran) With Brand Drug (RANEXA® 500 mg ER. tablets, Menarini Pharma, Luxemburg) in Iranian Healthy
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 (48h). 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 Ranolazin
Intervention groups
Intervention group 1: RANEXA® 500 mg tablet as a reference Intervention group 2:Ranolazine 500 mg extended-release 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:IRCT20200105046010N103
Registration date:2024-06-15, 1403/03/26
Registration timing:prospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
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 Ranolazine 500 mg extended-release tablets (Arang Pharma, Iran) With Brand Drug (RANEXA® 500 mg ER. tablets, Menarini Pharma, Luxemburg) in Iranian Healthy
Public title
In-vivo Bioequivalence Study of Ranolazine 500 mg extended-release tablets (Arang Pharma, Iran)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28) kg/m^2
Informed consent
Informed consentAge (18-55 years old)
Exclusion criteria:
Nicotine consumption
historyCardiovascular disease
disease HistoryLiver and kidney disease
HistoryAlcohol and opioid addiction
Allergy reactions history to Linagliptin or Metformin
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:
40
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: Daru Darman Arang 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.
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
No. 48, Ferdows street, Ferdowsi Sq.
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.TBZMED.REC.1403.170
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، 1.5، 2، 2.5، ،3، 3.5، 4، 4.5، 5، 5.5، 6،6.5 ، 7، 8، 10، 12، 24 , 48 h 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 RANEXA® 500 mg ER. tablets, Menarini Pharma, Luxemburg). after washout period, the volunteers receive Ranolazine 500 mg extended-release tablets (Arang Pharma, Iran).
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: Single dose, one oral Ranolazine 500 mg extended-release tablets (Arang Pharma, Iran) as test product.after washout period, the volunteers receive RANEXA® 500 mg ER. tablets, Menarini Pharma, Luxemburg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Radin laboratory
Full name of responsible person
Bahram Ataii
Street address
No.22, first floor, Moalem st., Abureihan St
City
Tabriz
Province
East Azarbaijan
Postal code
5154995671
Phone
+98 914 311 5717
Email
ataii.bahram@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arang Pharm Co.
Full name of responsible person
Alireza Mahbobian
Street address
No. 1, Unit 1, Saeb Tabrizi Gharbi St., Sheikh Bahaei St., Molla Sadra St., Tehran
City
Tehran
Province
Tehran
Postal code
1993674855
Phone
+98 21 8805 4460
Email
info@arangpharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arang Pharm 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, 10th Ave. Boostan Street, Roshdieh, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155935357
Phone
+98 41 3661 4125
Fax
Email
shokri.j@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, 10th Ave. Boostan Street, Roshdieh, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155935357
Phone
+98 41 3661 4125
Fax
Email
shokri.j@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, 10th Ave. Boostan Street, Roshdieh, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5155935357
Phone
+98 41 3661 4125
Fax
Email
shokri.j@gmail.com
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
These data are as secure between researchers and related industries.