Protocol summary

Summary
This randomized, single-dose, three-way, crossover study is conducted to compare the relative bioavailability of three formulations of sertraline hydrochloride tablets under fasting conditions in 24 healthy adults male volunteers. In each study period, a single 100 mg dose is administered to the subjects following an overnight fast of at least 10 hours. The test formulations are sertraline hydrochloride 50 and 100 mg tablets manufactured by Sobhandarou and the reference formulation is ZOLOFT® (sertraline hydrochloride) 100 mg tablet manufactured by Pfizer. The subjects will receive the test products and the reference product in three periods; the order of administration will be according to the dosing randomization schedule. There will be a 7-day interval between treatments. Venous blood (3 ml) for the determination of sertraline in plasma is sampled before dosing and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours after dosing (a total of 14 samples per profile). Criteria for the evaluation include the time course of the plasma concentrations of sertraline over the 72 h after the administration of the products as summarized by the area under the curve from time zero to infinity (AUC0-inf), the maximum plasma concentration (Cmax), time to reach Cmax (Tmax) and plasma half-life (t1/2). Statistical analysis is performed to evaluate the relative bioavailability of the test formulations to that of the reference product.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022813776N3
Registration date: 2016-12-27, 1395/10/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-27, 1395/10/07
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
Sobhandarou Pharmaceutical Company
Expected recruitment start date
2016-11-25, 1395/09/05
Expected recruitment end date
2017-02-08, 1395/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to compare the relative bioavailability of Sobhandarou and Pfizer formulations of sertraline 50 and 100 mg tablets in 24 healthy adult male volunteers under fasting conditions
Public title
Bioequivalence study of sertraline hydrochloride 50 and 100 mg tablets under fasting conditions
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1. Males, 18-50 years of age (inclusive). 2. The subject is able and willing to provide written informed consent. 3. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. 4. The subject has stable residence and telephone. 5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Exclusion criteria: 1. History of allergy or sensitivity to sertraline hydrochloride or other selective serotonin reuptake inhibitor's (SSRI's), or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. 2. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 3. Presence of gastrointestinal disease or history of malabsorption within the last year. 4. History of psychiatric disorders occurring within the last two years that required hospitalization or medication. 5. Presence of a medical condition requiring regular treatment with prescription drugs. 6. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. 7. Use within 7 days of dosing, or anticipated use during the study, or for 7 days after the last dose of sertraline any monoamine oxidase inhibitors (MAOIs). 8. Receipt of any drug as part of a research study within 30 days prior to dosing. 9. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing.
Age
From 18 years old to 50 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
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
Gorgan, Km 2 Sari Road
City
Gorgan
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
ir.goums.rec.1395.184

Health conditions studied

1

Description of health condition studied
Antidepressant drugs
ICD-10 code
F32
ICD-10 code description
Healthy volunteers

Primary outcomes

1

Description
Drug plasma concentration
Timepoint
After intervention
Method of measurement
Blood sampling

Secondary outcomes

1

Description
Time to reach Cmax
Timepoint
After intervention
Method of measurement
Blood sampling

Intervention groups

1

Description
Single dose of two sertraline 50 mg tablets (100 mg) manufactured by Sobhandarou
Category
Treatment - Drugs

2

Description
Single dose of one sertraline 100 mg tablet manufactured by Sobhandarou
Category
Treatment - Drugs

3

Description
Single dose of one Zoloft (sertraline) 100 mg tablet manufactured by Pfizer
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dialysis Center
Full name of responsible person
Mr. Ghezelsefloo
Street address
Shaheed Motahhari Hospital
City
Gonbade Kavous

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sobhandarou Pharmaceutical Company
Full name of responsible person
Mrs. Loghmanifar
Street address
Central Office, West Fatemi Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sobhandarou Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan Bioanalysis Center
Full name of responsible person
Dr. Hossein Amini
Position
Head of Center
Other areas of specialty/work
Street address
Golshahr Bolv., Golshahr 14, Aftabgardan Bulding, No. 6
City
Gorgan
Postal code
Phone
+98 17 3252 5972
Fax
Email
haminhplc@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Hossein Amini
Position
Associtate Professor, Ph.D
Other areas of specialty/work
Street address
University Main Campus
City
Gorgan
Postal code
Phone
+98 17 3252 5972
Fax
Email
haminhplc@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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