IRCT | In- Vivo Bioequivalence study of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) with brand drugs (Stalevo 200/50/200mg Novartis, Germany) in Iranian healthy volunteers.

Protocol summary

Study aim: In- Vivo Bioequivalence study of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) with brand drugs (Stalevo 200/50/200mg Novartis, Germany) in Iranian healthy volunteers.
Design: Single dose, randomized, two sequences, two period crossover with a washout period.
Settings and conduct: This study will be conducted in two-way, cross-over and fasting, and on two sets of healthy volunteers. The study will be conducted in two periods of twenty-four hours.The interval between these two periods, which is called the wash-out time, is determined by the half-life of the drug plasma, which according to scientific sources should be at least 5 to 7 half-life of the drug in the case of the drug under study. The plan will take a week to clean up the drug, given the biological half-life of the drugs in the drug form.In the first round, candidates are divided into two groups, and the first group receives a test tablet and the second group receives a similar tablet. Blood samples will taken by the volunteer by the technician immediately after taking the drug, and the preparation steps of the samples, including plasma separation and drug extraction, are performed to analyze the amount of drug on them.
Participants/Inclusion and exclusion criteria: 24 participants will be selected from non-smoking, not pregnant people with no history of heart, kidney and liver disease or dis functions with both sex (male&female). The ages and BMIs of participant should be in the range of 18-60 and 18-25 respectively.
Intervention groups: Both groups received in cross-over design medication and testing at two different cross-sections and Therefor,the test results are independent of individual differences and it will only show the difference in the formulation of the two drugs.
Main outcome variables: Cmax,Tmax, T1/2, Ke (Elemination)

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200105046010N9

Registration date: 2020-09-13, 1399/06/23

Registration timing: prospective

Last update: 2020-09-13, 1399/06/23

Update count: 0
Registration date: 2020-09-13, 1399/06/23

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: 2020-09-24, 1399/07/03
Expected recruitment end date: 2021-04-23, 1400/02/03
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: In- Vivo Bioequivalence study of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) with brand drugs (Stalevo 200/50/200mg Novartis, Germany) in Iranian healthy volunteers.

Public title: Study of bioequivalence of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) and foreign samples on 24 healthy Iranian volunteers.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

General health ( liver , heart , kidney ) Body mass index (18-28 ) Informed consent Age (18-60 )

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 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

Individuals are randomly selected with advertising 24 volunteers categorized in two sequences randomly.the type of drug (Sample and Brand drug) will prescribe with lottery.The number of individuals will be randomly selected and the first twelve will be selected as the first sequence and the second twelve will be selected as the second sequence.

Blinding (investigator's opinion)

Single blinded

Blinding description

This study is a blind side clinical trial (volunteers). Staparkin and Stalevo® 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 dosage form

Placebo

Not used

Assignment

Crossover

Other design features

Tow period / Tow sequence with a washout time

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Tabriz University of Medical Sciences Ethics Committee

Street address

Tabriz. No.48,Ferdows street, Ferdowsi Sq.

City

Tabriz

Province

East Azarbaijan

Postal code

51678744
Approval date: 2020-06-22, 1399/04/02
Ethics committee reference number: IR.TBZMED.REC.1399.314

Health conditions studied

1

Description of health condition studied: In this study the bioequivalence of test and brand of Staperkin will be evaluated.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Plasma drug concentration
Timepoint: Hour
Method of measurement: Blood sampling

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: Single dose of levodopa / carbidopa / entocapone citalopram 200/200/200 mg tablets (TALEVO® 200/50 / 200mg. NOVARTIS, Germany) Pharmaceutical Company as a reference product.
Category: Treatment - Drugs

2

Description: Intervention group: Single dose of Levodopa / Kirby Dopa / Entapapon Citalopram 200/50/200 mg Fanda Pharmaceutical Company (STAPARKIN® 200/50/200) as a test product.
Category: Treatment - Drugs

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, Ferdows Street

City

Tabriz

Province

East Azarbaijan

Postal code

5167874434

Phone

+98 41 3384 2724

Email

Shokri.j@gmail.com

1

Sponsor: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Aliakbar Sari Sarraf

Street address

No. 323, Second Floor, between Vazra St. and Valiasr St., Shahid Beheshti St., Tehran

City

Tehran

Province

Tehran

Postal code

3188115981

Phone

+98 21 8604 6304

Email

info@Fandapharma.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Tabriz University of Medical Sciences
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: Other

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

Tabriz University of Medical Sciences, Faculty of Pharmacy

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

Tabriz University of Medical Sciences, Faculty of Pharmacy

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

Tabriz University faculty of pharmacy

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: 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: Contact with E-mail of the main researcher.
What processes are involved for a request to access data/document: Personal and academic details and the aim of the request.
Comments

In- Vivo Bioequivalence study of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) with brand drugs (Stalevo 200/50/200mg Novartis, Germany) in Iranian healthy volunteers.