Randomized, single-dose, crossover comparative bioequivalence study of the Macitentan 10 mg tablets produced by Nano Fanavaran Darouyi Alvand pharmaceutical Co versus Opsumit® (Janssen company) in 24 healthy males under fasting conditions
To demonstrate bioequivalence of single dose test formulation of Nano Fanavaran Darouyi Alvand Macitentan 10 mg tablets versus Opsumit®(Janssen Co.)
Design
Single dose, randomized and crossover bioequivalence study of Macitentan 10 mg tablets by Nano Fanavaran Darouyi Alvand with Opsumit® (Janssen Co.) in 24 healthy male
Settings and conduct
Study place: Drug Applied Research Center affiliated to Tabriz University of Medical Science. Place for Blood and plasma sample analysis: Imam Reza Medical Research and Trainning Hospital. 24 healthy male volunteers will receive each of two test or reference Macitentan 10 mg tablets in random sequence according to the randomization schedule. The interval between receiving the medicine (washout period) is 7 days. Blood samples of volunteers at 0 (before dosing), 1، 2، 4، 5، 5.5، 6، 6.5، 7، 7.5، 8، 8.5، 9، 9.5، 10 ،12، 24، 36 ، 48 and 72 hour after dosing will be collected.
Participants/Inclusion and exclusion criteria
Healthy male subjects in the age range of 18-60 years with BMI (Body Mass Index) of 18.5-30. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed. Candidates who have consented to the informed consent form. Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Macitentan or any ingredients. Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Intervention groups
Intervention group 1: Macitentan 10 mg tablet produced by Nano Fanavaran Darouyi Alvand Co. is the test product. Intervention group 2: Macitentan 10 mg tablets (Opsumit), produced by Janssen Company is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Main outcome variables
Peak Plasma Concentration (Cmax); Area under the concentration-time curve (AUC).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200407046981N18
Registration date:2021-10-09, 1400/07/17
Registration timing:prospective
Last update:2021-10-09, 1400/07/17
Update count:0
Registration date
2021-10-09, 1400/07/17
Registrant information
Name
Fatima Molavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 2700
Email address
molavif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, single-dose, crossover comparative bioequivalence study of the Macitentan 10 mg tablets produced by Nano Fanavaran Darouyi Alvand pharmaceutical Co versus Opsumit® (Janssen company) in 24 healthy males under fasting conditions
Public title
Study of absorption and elimination rate of Macitentan 10 mg tablets in comparison with standard tablets of Macitentan (Opsumit®).
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy male subjects in the age range of 18-60 years with BMI (Body Mass Index) of 18.5-30.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Candidates who have consented to the informed consent form.
Exclusion criteria:
Known hypersensitivity or idiosyncratic reaction to Macitentan or any ingredients.
Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Age
From 18 years old to 60 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope after entering the study, and numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of the both groups will change for the second period.
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 Tabriz University of Medical Science
Street address
Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.472
Health conditions studied
1
Description of health condition studied
In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Macitentan 10 mg of test and reference in healthy volunteers.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
At 0 (before dosing), 1، 2، 4، 5، 5.5، 6، 6.5، 7، 7.5، 8، 8.5، 9، 9.5، 10 ،12، 24، 36 ، 48 and 72 hour after dosing
At 0 (before dosing), 1، 2، 4، 5، 5.5، 6، 6.5، 7، 7.5، 8، 8.5، 9، 9.5، 10 ،12، 24، 36 ، 48 and 72 hour after dosing
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS
Intervention groups
1
Description
Intervention group 1: Macitentan 10 mg tablet produced by Nano Fanavaran Darouyi Alvand Co. 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 2: Macitentan 10 mg tablets (Opsumit), produced by Janssen Company is the reference 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
Drug Applied Research Center
Full name of responsible person
Dr Hamed Hamishehkar
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Fax
+98 41 3336 7914
Email
hamishehkar.hamed@gmail.com
Web page address
https://darc.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nano Fanavaran Darouyi Alvand pharmaceutical Co
Full name of responsible person
Nima Sepehri
Street address
No. 1462, Center of pharmaceutical incubator, Next to University Alley, Above Jalal Al-Ahmad, North Amirabad St., Tehran University of Medical Sciences,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8802 0579
Fax
Email
info@nanoalvand.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nano Fanavaran Darouyi Alvand 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
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Email
Hamishehkar.hamed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Emami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7111
Fax
+98 31 3668 0011
Email
Emami@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatima Molavi
Position
PhD student of Pharmaceutics
Latest degree
Medical doctor
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 2700
Fax
Email
Molavif@tbzmed.ac.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