IRCT | In- Vivo Bioequivalence study of Flecainide acetate tablet 100 mg Arena Hayat Danesh Pharma. (TAMONID® 100mg) with brand drug (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) in Iranian healthy volunteers.

Protocol summary

Study aim: In- Vivo Bioequivalence study of Flecainide acetate tablet 100 mg Arena Hayat Danesh Pharma (TAMONID® 100mg ) with brand drug (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) in Iranian healthy volunteers.
Design: In-vivo bioequivalence study of Flecainide acetate tablet 100 mg Arena Hayat Danesh Pharma in compared with reference drug (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA). The single-blind, Cross-over, two-period, two groups (intervention and control) and randomized (paper lottery randomization method) study with one week wash-out time.
Settings and conduct: This study is carried out in Simin Baspar Tayf-Gostar Company, Tabriz, Iran. The study population is 24 healthy Iranian volunteers.This study is a single blind study and by taking out the drugs from the existing packaging, the volunteers will not know the time of receiving the test drug and the brand. This study is a cross over study that is performed in two time periods of 72 hours with a two-week wash-out period.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Age between 18-55 years, body mass index (BMI) in the range of 18-28. Exclusion criteria: History of heart, kidney and liver disease, Pregnancy, Drug addiction, Smoking
Intervention groups: Single dose Flecainide acetate tablet 100 mg Arena Hayat Danesh Pharma. Control group: brand drugs (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA )
Main outcome variables: Plasma drug concentration

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200105046010N48

Registration date: 2021-12-19, 1400/09/28

Registration timing: registered_while_recruiting

Last update: 2021-12-19, 1400/09/28

Update count: 0
Registration date: 2021-12-19, 1400/09/28

Registrant information: Name

Javad Shokri

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 41 3661 4125

Email address

shokri.j@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-12-08, 1400/09/17
Expected recruitment end date: 2022-07-08, 1401/04/17
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: In- Vivo Bioequivalence study of Flecainide acetate tablet 100 mg Arena Hayat Danesh Pharma. (TAMONID® 100mg) with brand drug (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) in Iranian healthy volunteers.

Public title: In-vivo Bioequivalence Test of Flecainide acetate tablets with brand drug (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

General health Body mass index between18-28 Informed consent Being at the age of 18-55 years old

Exclusion criteria:

Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug
Age: From 18 years old to 55 years old
Gender: Both

Phase

Bioequivalence

Groups that have been masked

Participant

Sample size

Target sample size: 24

Randomization (investigator's opinion)

Randomized

Randomization description

For this purpose, A 24- persons group will be selected and divided to two 12-persons groups randomly. The names of all volunteers will be written on paper pieces and wrapped in aluminum foils. The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B.

Blinding (investigator's opinion)

Single blinded

Blinding description

Candidates are not aware of receiving the test drug or brand one. In a one-blind study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Test and Brand drugs are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test drug.

Placebo

Not used

Assignment

Crossover

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Tabriz University of Medical Sciences

Street address

Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St.

City

Tabriz

Province

East Azarbaijan

Postal code

5166614766
Approval date: 2021-11-15, 1400/08/24
Ethics committee reference number: IR.TBZMED.REC.1400.734

Health conditions studied

1

Description of health condition studied: Bio equivalence test
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Plasma drug concentration
Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 48, 72 hours after prescribing the tablet.
Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: One test tablet (Flecainide tablet 100 mg produced by Arena Hayate Danesh Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector. After one week wash out period, the test drug taken by other sequence of volunteers.
Category: Treatment - Other

2

Description: Control group: One Reference tablet (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of Flecainide in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. After one week wash out period, the test drug taken by other sequence of volunteers.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Simin Baspar Teyf Gostar Company

Full name of responsible person

Javad Shokri

Street address

No.48, Ferdos square

City

Tabriz

Province

East Azarbaijan

Postal code

5167874434

Phone

+98 41 3384 2724

Email

Shokri.j@gmail.com

1

Sponsor: Name of organization / entity

Arena Hayat Danesh Pharmaceutical Company

Full name of responsible person

Mahsa Alizade

Street address

Unit 6, 3rd Floor, No. 16, West Zayandeh Rd Alley, North Shiraz St., Mollasadra Bank, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1991613857

Phone

+98 21 8862 8449

Email

info@arenalifescience.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Arena Hayat Danesh 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

Tabriz University of Medical Sciences

Full name of responsible person

Javad Shokri

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah

City

Tabriz

Province

East Azarbaijan

Postal code

5166414766

Phone

+98 41 3334 8489

Email

Shokri.j@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Javad Shokri

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Medical Pharmacy

Street address

Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah

City

Tabriz

Province

East Azarbaijan

Postal code

5166414766

Phone

+98 41 3334 8489

Email

Shokri.j@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Simin Baspar Teyf Gostar Company

Full name of responsible person

Dariush Omidar

Position

Lab. Manager

Latest degree

Master

Other areas of specialty/work

Others

Street address

No.48, Ferdos square

City

Tabriz

Province

East Azarbaijan

Postal code

5167874434

Phone

+98 41 3384 2724

Email

Dariush.omidfar@gmail.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: These date are as secure between researcher and related industries
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: Yes - There is a plan to make this available
Title and more details about the data/document: Only protocol and methods of study are sharable
When the data will become available and for how long: After finishing of the protocol (Probably 6 months receiving IRCT code)
To whom data/document is available: Pharmaceutical and medical sciences researchers
Under which criteria data/document could be used: Projects information's for any publications is not allowed.
From where data/document is obtainable: By email to the project manager (shokri.j@gmail.com)
What processes are involved for a request to access data/document: This information is confidential and is at the disposal of the project sponsor. Upon request, the information will be provided to the applicant by the contractor's email after the
Comments

In- Vivo Bioequivalence study of Flecainide acetate tablet 100 mg Arena Hayat Danesh Pharma. (TAMONID® 100mg) with brand drug (TAMBOCOR® 100 mg FC Tab, MEDA Pharmaceuticals LLC, USA) in Iranian healthy volunteers.