A study to compare the relative bioavailability of Razak and Eli Lilly formulations of fluoxetine 20 mg capsules in 24 healthy adult volunteers under fasting conditions
Bioequivalence evaluation of two capsule formulations of fluoxetine in healthy subjects under fasting conditions
Design
This randomized, single-dose, two-way, crossover study is conducted to compare the pharmacokinetics of fluoxetine and Prozak® capsules in 24 healthy adult volunteers. Volunteers will be sorted and receive a number from 1 to 24. In the first period of the study, 12 volunteers will receive fluoxetine manufactured by Razak and the remaining 12 volunteers will receive Prozak® produced by Eli Lilly company. The administered drugs will be replaced to another group in the second period of the study. َA washout period of 1 week is allowed between doses.
Settings and conduct
The dose administration and subsequent sample collection will be performed in Motahhari hospital (Gonbade Kavous, Iran).
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 18-55 years old; subject available for the entire study period; willingness to adhere to protocol requirements as evidenced by written informed consent; good health at screening. Exclusion criteria: History of use 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 40 mg oral dose of fluoxetine (2 capsules) manufactured by Razak company to 12 subjects. Second intervention group: A single 40 mg oral dose of Prozak (2 capsules) manufactured by Eli Lilly company to 12 subjects. Since the volunteers of the present study 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:IRCT20130626013776N115
Registration date:2024-08-10, 1403/05/20
Registration timing:registered_while_recruiting
Last update:2024-08-10, 1403/05/20
Update count:0
Registration date
2024-08-10, 1403/05/20
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
recruiting
Funding source
Expected recruitment start date
2024-07-26, 1403/05/05
Expected recruitment end date
2025-07-27, 1404/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to compare the relative bioavailability of Razak and Eli Lilly formulations of fluoxetine 20 mg capsules in 24 healthy adult volunteers under fasting conditions
Public title
Bioequivalence study of fluoxetine 20 mg capsules
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
18-55 years of age
The subject is able and willing to provide signed informed consent
Willing to adhere to protocol requirements as evidenced by written informed consent
The subject has a stable residence and telephone
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
Exclusion criteria:
History of allergy or sensitivity to fluoxetine
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
Male
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
In a crossover design, each person is its own control and receives two different interventions
Randomization (investigator's opinion)
Randomized
Randomization description
A pot sampling method will be used in this study. 12 papers are labeled "Reference Product" and 12 papers are written as "Test Product". The papers are then placed in sealed envelopes, and participants randomly select a paper and will be placed in the Reference or Test groups.
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
Golestan University of Medical Sciences
Street address
Falsafi complex, Sari road km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2024-07-09, 1403/04/19
Ethics committee reference number
IR.GOUMS.REC.1403.134
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maximum plasma drug concentration
Timepoint
At time zero and 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 48 and 72 h after drug administration
Method of measurement
Blood sampling and measurement of drug concentrations by high-performance liquid chromatography
2
Description
Area under plasma concentration-time curve
Timepoint
At time zero and 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 48 and 72 h after drug administration
Method of measurement
Blood sampling and measurement of drug concentrations by high-performance liquid chromatography
Secondary outcomes
1
Description
Time to reach Cmax
Timepoint
At time zero and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h after drug administration
Method of measurement
Blood sampling and measurement of drug concentrations by high-performance liquid chromatography
2
Description
Plasma half-life
Timepoint
By using concentration at time points of 8, 10, 24, 48 and 72
Method of measurement
Blood sampling and drug analysis by high-performance liquid chromatography method
Intervention groups
1
Description
Intervention group 1: Oral administration of a single 40 mg dose of fluoxetine (2 capsules) manufactured by Razak to healthy volunteers under fasting condition in the morning of the experiment day
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral administration of a single 40 mg dose of Prozak (2 capsules) manufactured by Eli Lilly to healthy volunteers under fasting condition in the morning of the experiment day
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
Razak Pharmaceutical Company
Full name of responsible person
Fatemeh Mohammadloo
Street address
Looleh Profil Street, Tehran-Karaj Makhsoos Road, Km 10
City
Tehran
Province
Tehran
Postal code
1389736615
Phone
+98 21 4452 5413
Fax
+98 21 4452 5410
Email
info@razakpharma.com
Web page address
http://razakpharma.com
Grant name
Bioequivalence Study of fluoxetine
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Razak Pharmaceutical 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
Falsafi educational complex, Sari Road km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 1442 1651
Fax
+98 17 1442 1289
Email
hamini@sbmu.ac.ir
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
Falsafi educational complex, Sari Road km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 1442 1651
Fax
+98 17 1442 1289
Email
hamini@sbmu.ac.ir
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
Falsafi educational complex, Sari Road km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 1442 1651
Fax
+98 17 1442 1289
Email
hamini@sbmu.ac.ir
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