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Comparative bioequivalence study of Finasteride 5 mg Tablet of Iran Hormone. and Finasteride® of 1A Pharma GmbH as reference in 24 healthy male under fasting.

Protocol summary

Study aim
This study will be performed to compare the pharmacokinetics and invivo parameters of Finasteride 1 mg Tablet formulation as a test product with Finasteride 1 mg Tablet at 1A Pharma GmbH formulation as a reference product to evaluate the bioequivalence.
Design
Non-blinded, randomized, crossover in vivo bioequivalence study in 24 healthy males under fasting conditions. Block randomization for a treatment sequence of Test/Reference or Reference/Test is used.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Noor Research and Development Institute (Tarasht, Tehran). Then 16 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours and non-blinded.2 dosing periods will be separated by a 7-day washout period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2. Exclusion criteria: Subjects with known allergy to the products tested.
Intervention groups
Intervention group 1: Finasteride 1 mg Tablet, produced by Iran Hormone Pharmaceutical Co.is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. After 7-day wash-out period the intervention 2 will be given to these subjects. Intervention group 2: Finasteride 1 mg Tablet, produced by 1A Pharma GmbH is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product. After 7-day wash-out period the intervention 1 will be given to these subjects.
Main outcome variables
Peak Plasma Concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180620040164N71
Registration date: 2024-11-02, 1403/08/12
Registration timing: prospective

Last update: 2024-11-02, 1403/08/12
Update count: 0
Registration date
2024-11-02, 1403/08/12
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
2024-11-25, 1403/09/05
Expected recruitment end date
2024-12-09, 1403/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Finasteride 5 mg Tablet of Iran Hormone. and Finasteride® of 1A Pharma GmbH as reference in 24 healthy male under fasting.
Public title
Comparative in vivo evaluation of 2 Finasteride 1 mg Tablet formulations.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) between 20 – 45 years of age. Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
Exclusion criteria:
Subjects with known allergy to Tested Product.Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study. Married candidates are advised to strictly refrain from sexual intercourse during the test and in the sampling interval.
Age
From 20 years old to 45 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
The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer's number (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer.
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,School of Pharmacy,Nursing&Midwifery-Shahid Beheshti University of medical sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2024-10-21, 1403/07/30
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.143

Health conditions studied

1

Description of health condition studied
Enlarged prostate
ICD-10 code
N40
ICD-10 code description
Enlarged prostate

Primary outcomes

1

Description
Peak Plasma Concentration (Cmax)
Timepoint
16 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours
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
16 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12 and 24 hours
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)

Intervention groups

1

Description
Intervention group1:(Test) Finasteride 1 mg tablet, produced by Iran Hormone Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 2 will be given to these subjects.
Category
Treatment - Drugs

2

Description
Intervention group 2: (Reference) Finasteride 1 mg tablet produced by 1A Pharma GmbH is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 1will be given to these subjects.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor Research & Development Institute (Tavan)
Full name of responsible person
Behzad Montaha Sangari
Street address
Sharif Innovation Station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran Hormone Pharmaceutical Co.
Full name of responsible person
Mehdi Amani
Street address
Km 11 Karaj Makhsous Road, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1399813611
Phone
+98 21 4490 5517
Email
info@iranhormone.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Hormone Pharmaceutical Co.
Proportion provided by this source
100
Public or private sector
Public
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
Behzad Montaha sangari
Position
chief executive officer (CEO)
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, 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 Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
mforoutan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Behzad Montaha sangari
Position
chief executive officer (CEO)
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
Behzad_first@yahoo.com

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
No - There is not 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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