A randomized, open label, single dose, crossover, bioequivalence study of Prazosin 5mg tablet produced by Amin Pharm Co., IRAN in comparison owith MiniPress 5mg tablet produced by Laphal Co. in 24 healthy adult subjects under fasting condition
A randomized, crossover bioequivalence study of single dose of test formulation (Prazosin 5mg tablet of Amin Pharm Co., IRAN) in comparison of reference product (MiniPress 5mg tablet of Laphal) by means of AUC0-t and Cmax in healthy adult human subjects under fasting conditions.
Design
A randomized, open label, single dose, crossover, bioequivalence study in 24 healthy subjects under fasting condition
Settings and conduct
This study is carried out in Core Research Center of Zahedan University of Medical Sciences located in Imam Ali Hospital in Zahedan. There is a separate space for sampling and forecasting emergency situations in order to accommodate and rest the volunteers. This crossover and open label study was performed on 24 healthy volunteers. The volunteers' health is verified by the project physician prior to entry into the study, and the volunteers' status is regularly monitored by the project physician on the day of drug administration. This study will be covered by insurance in order to compensate for any adverse effects.
Participants/Inclusion and exclusion criteria
Main Inclusion criteria: Healthy subjects aged between 18 -50 years old; weighted between 50 – 100 kg. Main exclusion criteria: History of the gastro-intestinal tract surgery; Donation a unit of blood or participated in another clinical trial within the last two months; History of drug or alcohol abuse; Used any medication within 7- 14 days before the first treatment;
Intervention groups
Intervention: Single dose of one Prazosin 5mg tablet of Amin Pharm Co, IRAN
Control: Single dose of one MiniPress 5mg tablet of Laphal
Main outcome variables
Plasma concentration of Prazosin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190706044111N27
Registration date:2022-01-12, 1400/10/22
Registration timing:prospective
Last update:2022-01-12, 1400/10/22
Update count:0
Registration date
2022-01-12, 1400/10/22
Registrant information
Name
Ladan Tayebi
Name of organization / entity
Pars Biopharmacy Research Co.
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 6061
Email address
l.tayebi@parsbiopharmacy.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-20, 1401/01/31
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized, open label, single dose, crossover, bioequivalence study of Prazosin 5mg tablet produced by Amin Pharm Co., IRAN in comparison owith MiniPress 5mg tablet produced by Laphal Co. in 24 healthy adult subjects under fasting condition
Public title
Bioequivalence study of Prazosin 5mg tablet of Amin Pharm Co., IRAN
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 - 50 years
Body weight between 50 – 100 kg
Having good health on the basis of medical history and physical & clinical examination
Understand the procedures and give written informed consent
Exclusion criteria:
History of the gastro-intestinal tract surgery
Subject with a history of blood donation or participation in another clinical trial, within the last two months before the first treatment
Subject with a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject with a history of disease leading to using drug within 14 days, or any non-prescription medication within 7 days, before the first treatment.
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:
2
Each volunteer, 2 times take medicine in the study. One-time test product and the other time reference product with at least one week wash-out period.
Randomization (investigator's opinion)
Randomized
Randomization description
Using the rand command in Excel software, one of the sequences AB (test-reference product) or BA (reference-test product) is randomly assigned to each volunteer at random.
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 Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences; Dr. Hessabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.ZAUMS.REC.1400.309
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Plasma concentration of prazosin after single dose of 5mg prazosin tablet
Timepoint
at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0 & 10.0 hr. after dosing
Method of measurement
High Performance Liquid Chromatography (HPLC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prazosin, one 5mg tablet, produced by Amin Pharm Co. (IRAN), single dose
Category
Other
2
Description
Control group: MiniPress, one 5mg tablet, produced by Laphal company, single dose.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Core Research Lab. of Zahedan University of Medical Sciences
Full name of responsible person
Marzyeh Ghasemi
Street address
Emam Ali Hospital, Salamat Blv., Khalij-e-Fars Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5664
Fax
+98 54 3329 5665
Email
crl@zaums.ac.ir
Web page address
http://crl.zaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Amin Pharm. Co.
Full name of responsible person
Mohammad Mahdy Hoghoughi
Street address
Nejatbakhsh Boulevard
City
Falavarjan
Province
Isfehan
Postal code
8459143344
Phone
+98 31 3725 2900
Fax
+98 31 3725 2898
Email
info@aminpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Amin 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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
First floor, No 5, Saeidi Dead-end alley, Palestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
First floor, No 5, Saeidi Dead-end alley, Palestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com
Person responsible for updating data
Contact
Name of organization / entity
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
First floor, No 5, Saeidi Dead-end alley, Palestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com
Web page address
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