A study to compare the relative bioavailability of paroxetine 20 mg tablets manufactured by Abian Pharmed and GlaxoSmithKline company (Paxil®) in 24 healthy adult volunteers under fasting conditions
The study aim is to evaluate the bioequivalence of paroxetine 20 mg tablets produced by two different pharmaceutical companies under fasting condition.
Design
This randomized, single-dose, two-way, crossover study is conducted to compare the pharmacokinetic of paroxetine and Paxil® tablets in 24 healthy adults volunteers. Volunteers will be sorted and receive a number from 1 to 24. In the first phase of the study, 12 volunteers will receive paroxetine manufactured by Abian Pharmed and the remaining 12 volunteers will receive Paxil® produced by GlaxoSmithKline company. The administered drugs will be replaced by each other in the second phase of the study.
Settings and conduct
The dose administration and subsequent sample collection will be performed in Shahid Motahhari hospital (Gonbade Kavous, Iran).
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-55 years of age; good health at screening. Non-inclusion criteria: History of any drug hypersensitivity or intolerance; significant history or current evidence of chronic disease; receipt of any drug as part of a research study within 30 days prior to the present study.
Intervention groups
First intervention group: A single 20 mg oral dose of Paroxetine (1 tablet) manufactured by Abian Pharmed company to 12 subjects. Second intervention group: A single 20 mg oral dose of Paxil (1 tablet) manufactured by GlaxoSmithKline company to 12 subjects. Since in this study, the volunteers will receive both Test and Reference drugs, each volunteer will act as his own control.
Main outcome variables
Drug plasma concentration; Area under the plasma concentration-time curve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130626013776N36
Registration date:2021-04-13, 1400/01/24
Registration timing:prospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Hossein Amini
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1651
Email address
hamini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to compare the relative bioavailability of paroxetine 20 mg tablets manufactured by Abian Pharmed and GlaxoSmithKline company (Paxil®) in 24 healthy adult volunteers under fasting conditions
Public title
Bioequivalence study of paroxetine 20 mg tablets
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
18-55 years of age
The subject is able and willing to provide signed informed consent
The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent
The subject has stable residence place and telephone
Good health as determined by absence of clinically significant abnormalities in health assessments performed at screening
Exclusion criteria:
History of allergy or sensitivity to paroxetine
History of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject of the study
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction
Presence of gastrointestinal disease or history of malabsorption within the last year
History of a medical disorders occurring within the last year that required hospitalization or medication
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing
Receipt of any drug as part of a research study within 30 days prior to the present study
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study
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:
0
A volume of 3 ml of blood is obtained in each sampling time through a venous cannula
Randomization (investigator's opinion)
Randomized
Randomization description
Each subject is identified by a number from 1 to 24. This number is allocated according to their entrance to volunteers' list in the screening day. Then, by using a prepared random number table, the participants are randomized into two sequences of Test/Reference and Reference/Test products
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 Golestan University of Medical Sciences
Street address
Falsafi Building, 5th Km of Sari road
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.GOUMS.REC.1399.321
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maximum Drug plasma concentration
Timepoint
At time zero and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours after drug administration
Method of measurement
Blood sampling and measurement of drug concentrations by high-performance liquid chromatographic method
2
Description
Area under plasma concentration-time curve
Timepoint
At time zero and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours after drug administration
Method of measurement
Blood sampling and measurement of drug concentrations by high-performance liquid chromatographic method
Secondary outcomes
1
Description
Plasma half-life
Timepoint
From the terminal 60 hours of plasma concentration-time profile
Method of measurement
Blood sampling and drug analysis by HPLC
Intervention groups
1
Description
Intervention group 1: Oral administration of a single 20 mg dose of paroxetine (1 tablet) manufactured by Abian Pharmed to 12 healthy volunteers under fasting condition in the morning of the experiment day. After 1 week, these 12 volunteers will receive the Brand product.
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral administration of a single 20 mg dose of Paxil (1 tablet) manufactured by GlaxoSmithKline to 12 healthy volunteers under fasting condition in the morning of the experiment day. After 1 week, these 12 volunteers will receive the Test product.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Center, Shahid Motahhari Hospital
Full name of responsible person
Yahya Naserifard
Street address
Taleghani street
City
Gonbade Kavous
Province
Golestan
Postal code
4916817693
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abian Pharmed Company
Full name of responsible person
Dr. Behzad Taghipour
Street address
No 19, Parvin St, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1657167142
Phone
+98 21 2485 2000
Fax
+98 21 2485 2000
Email
info@abianpharmed.com
Grant name
Bioequivalence Study of Paroxetine
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Abian Pharmed 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
Gorgan University of Medical Sciences
Full name of responsible person
Hossein Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sari Road, Km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hossein Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
2th kilometer of Sari road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hossein Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
2th kilometer of Sari road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.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
Data are confidential and need permission from the company.