IRCT | In- Vivo Bioequivalence Study of Dimethyl fumarate 240 mg Enteric-coated test (DIPHOSEL® 240 mg EC. Caps. َAbidi, Iran) with brand drug (TECFIDERA® 240 mg, Biogen, Germany) in Iranian healthy volunteers.

Protocol summary

Study aim: In- Vivo Bioequivalence Study of Dimethyl fumarate 240 mg Enteric-coated test (DIPHOSEL® 240 mg EC. Caps. Abidi, Iran) with brand drug (TECFIDERA® 240 mg, Biogen, Germany) in Iranian healthy volunteers.
Design: In-vivo bioequivalence study of test (Dimethyl fumarate 240 mg Enteric-coated Capsules, Abidi, IRAN) in compared with reference drug (TECFIDERA® 240 mg, Biogen, Germany). The single blind, Cross-over, two period, two groups (Intervention and control) and randomized (paper lottery randomization method) study with one week wash-out period.
Settings and conduct: This study will carried out in Simin Baspar Tayf Gostar Company, Tabriz, Iran. The number of participant is 24 healthy Iranian volunteers. This study is single blind by taking the drugs out of their original packaging, the volunteers will not know the The types of receiving drugs (test or brand). This study is a cross over, two periods, two times (each times is 72 hours) with a one-week wash-out period.
Participants/Inclusion and exclusion criteria: Inclusion criteria: participants are between 18-60 years old, Normal body mass index (BMI in the range of 18-28). Exclusion criteria: smoking, History of heart, kidney or liver disease, Pregnancy, Drug addiction
Intervention groups: Single dose Dimethyl fumarate 240 mg Entric-coated Capsules Abidi Pharmaceuticals. Control group: brand drugs (TECFIDERA® 240 mg, Biogen, Germany)
Main outcome variables: Plasma drug concentration

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200105046010N43

Registration date: 2021-10-30, 1400/08/08

Registration timing: prospective

Last update: 2021-10-30, 1400/08/08

Update count: 0
Registration date: 2021-10-30, 1400/08/08

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: 2021-11-03, 1400/08/12
Expected recruitment end date: 2022-08-03, 1401/05/12
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: In- Vivo Bioequivalence Study of Dimethyl fumarate 240 mg Enteric-coated test (DIPHOSEL® 240 mg EC. Caps. َAbidi, Iran) with brand drug (TECFIDERA® 240 mg, Biogen, Germany) in Iranian healthy volunteers.

Public title: In-vivo Bioequivalence Test of Dimethyl fumarate Capsules with brand drug (TECFIDERA® 240 mg, Biogen, Germany)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

General health Body mass index between18-28 Informed consent Being at the age of 18-60 years old

Exclusion criteria:

Smoking History of cardiovascular disease History of liver or kidney disease Pregnancy Alcohol & Drug addiction History of hypersensitivity
Age: From 18 years old to 60 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 reason, A 24- person group will be selected and divided to two 12-person 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 drug (Dimethyl fumarate Capsules) are withdrawal from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about the types of receiving drugs (test or brand).

Placebo

Not used

Assignment

Crossover

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee, 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: 2021-05-17, 1400/02/27
Ethics committee reference number: IR.TBZMED.REC.1400.158

Health conditions studied

1

Description of health condition studied: Bioequivalence Study
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, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours after prescribing the tablet.
Method of measurement: High Performance Liquid Chromatography tandem mass spectroscopy

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: they will receive one test drug (Dimethyl fumarate 240 mg Entric-coated Capsulesو ABIDI Pharma. Iran). Blood samples will be taken during 72 hours at the mentioned times after drug administration and the concentration of Dimethyl fumarate in blood samples will be measured by liquid chromatography- Tandem mass spectroscopy method.
Category: Treatment - Other

2

Description: Control group: will receive one test drug (TECFIDERA® 240 mg, Biogen, Germany). Blood samples will be taken from the volunteers during 72 hours at the mentioned times after drug administration and the concentration of Dimethyl fumarate in blood samples will be measured by High performance liquid chromatography- Tandem mass spectroscopy method.
Category: 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 3693 4125

Email

Shokri.j@gmail.com

1

Sponsor: Name of organization / entity

ABIDI Pharmaceutical Company

Full name of responsible person

Farzaneh Jalilopur

Street address

8th km of Shahid Lashkari highway, Karaj special road. Obaidi Boulevard No. 72

City

Tehran

Province

Tehran

Postal code

1389776363

Phone

+98 21 4452 2451

Email

info@abidi-diabetes.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: ABIDI 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: Persons

Person responsible for general inquiries

Contact: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Javad Shokri

Position

Full 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

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 Street

City

Tabriz

Province

East Azarbaijan

Postal code

5166414766

Phone

+98 41 3334 8489

Email

Shokri.j@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: Only protocol and methods of study are shareable.
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 Dimethyl fumarate 240 mg Enteric-coated test (DIPHOSEL® 240 mg EC. Caps. َAbidi, Iran) with brand drug (TECFIDERA® 240 mg, Biogen, Germany) in Iranian healthy volunteers.