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Bioequivalence study of Mexiletine 200 mg capsule manufactured by Tadbir Kalaye Jam company in comparison with Mexiletine® 200 mg capsule ANNORA PHARMA PRIVATE LTD on healthy volunteers

Protocol summary

Study aim
Bioequivalence study of two Mexiletine 200 mg capsule manufactured by Tadbir Kalaye Jam company
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers, Two period, Simple randomization method will be used.
Settings and conduct
This study will be conducted in two-way, Two period (48 hr with 1 week washout time), Single blinded, cross-over and fasting, and on two sets of healthy volunteers. In the first round, candidates are divided into two sequence using randomization software. The first sequence (even numbers) receives a reference tablet and the second sequence (odd numbers) receives a similar tablet of the test. 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. Plasma concentration data will be analyzed by WinNonLin software. The study will be done in Radin Shimi Co.
Participants/Inclusion and exclusion criteria
Inclusion criteria: non-smoking, not pregnant, no history of heart, kidney and liver disease or disfunctions. The ages and BMIs of participant should be in the range of 18-55 and 18-30 respectively. Exclusion criteria: Smoking, History of cardiovascular, liver and kidney disease; Alcohol and drug addiction, History of allergy to drug.
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
Maximum concentration (Cmax), Time to reach maximum concentration (Tmax), Half life (T1/2), Elimination constant (Ke)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240803062623N12
Registration date: 2025-02-21, 1403/12/03
Registration timing: prospective

Last update: 2025-02-21, 1403/12/03
Update count: 0
Registration date
2025-02-21, 1403/12/03
Registrant information
Name
Mohammad Ali Karkhaneh Yousefi
Name of organization / entity
Tadbir Kalaye Jam co.
Country
Iran (Islamic Republic of)
Phone
+98 21 8866 8700
Email address
yousefi@tadbirkala.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2027-09-23, 1406/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Mexiletine 200 mg capsule manufactured by Tadbir Kalaye Jam company in comparison with Mexiletine® 200 mg capsule ANNORA PHARMA PRIVATE LTD on healthy volunteers
Public title
Bioequivalence study of two Mexiletine 200 mg capsule manufactured by Tadbir Kalaye Jam company
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age (18-55years old) General Health (Liver, Heart, and Kidney) Body Mass Index (18-30) Informed consent
Exclusion criteria:
Smoking history of cardiovascular disease history of liver & kidney disease Alcohol & Drug addiction Hypersensitivity to the drug Pregnancy
Age
From 18 years old to 55 years old
Gender
Both
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: 32
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People are checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24 using a randomization software. Even numbers will receive the reference and odd numbers will receive the test drug in the first period.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Test and Originator brand's tablets 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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
5th floor,No. 60, Mollasadra Ave, Vanak Sq
City
Tehran
Province
Tehran
Postal code
1435793175
Approval date
2025-01-21, 1403/11/02
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.185

Health conditions studied

1

Description of health condition studied
In this study the , the disease is not investigated , bioequivalence of test and brand drug will be evaluated.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Drug plasma concentration
Timepoint
0 , 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 3.5 , 4 , 5 , 6 , 8 , 10 , 12 , 24 , 48h after drug administration
Method of measurement
Liquid chromatography–mass spectrometry

Secondary outcomes

1

Description
Time to reach maximum plasma concentration
Timepoint
After intervention
Method of measurement
Time to reach the maximum drug concentration in plasma is recorded.

2

Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time

Intervention groups

1

Description
Intervention group: Single-dose of the test drug Mexiletine 200 mg capsule manufactured by Tadbir Kalaye Jam company
Category
Treatment - Drugs

2

Description
Control group: Single-dose of the reference drug Mexiletine® 200 mg capsule ANNORA PHARMA PRIVATE LTD in the first period.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Asr Nano company
Full name of responsible person
Mohammad Ali Karkhaneh Yousefi
Street address
Asr Nano company, Polymer research institute, Pajuhesh boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۹۷۷۱۳۱۱۶
Phone
+98 21 4478 7091
Email
yousefi@tadbirkala.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tadbir Kala Jam
Full name of responsible person
Mohammad Ali Karkhane Yosefi
Street address
5th floor, No.60, Mollasadra Ave، Vanak squre
City
Tehran
Province
Tehran
Postal code
1435793175
Phone
+98 21 8866 8700
Fax
+98 21 8866 8710
Email
n.mohammadi@tadbirkala.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tadbir Kala Jam
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
Tadbir Kalaye Jam co.
Full name of responsible person
Mohammad Ali Karkhaneh Yousefi
Position
Medical Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 60 , Mollasadra Ave., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435793175
Phone
+98 21 8866 8700
Fax
+98 21 8866 8710
Email
yousefi@tadbirkala.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tadbir Kalaye Jam co.
Full name of responsible person
Mohammad Ali Karkhaneh Yousefi
Position
Medical Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 60 , Mollasadra Ave., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435793175
Phone
+98 21 8866 8700
Fax
+98 21 8866 8710
Email
yousefi@tadbirkala.com

Person responsible for updating data

Contact
Name of organization / entity
Tadbir Kalaye Jam Co.
Full name of responsible person
Mohammad Ali Karkhaneh Yousefi
Position
Medical Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
5th floor, No. 60, Mollasadra Ave, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435793175
Phone
+98 21 8866 8700
Fax
+98 21 8866 8710
Email
yousefi@tadbirkala.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 data are as secure between researchers 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
No - There is not a plan to make this available
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