Bioequivalence study of methylphenidate hydrochloride 10 mg tablet of Jalinous pharmaceutical company compared to methylphenidate hydrochloride 10 mg sample of Novartis company in Switzerland on healthy volunteers
Bioequivalence study of methylphenidate hydrochloride 10 mg tablet of Jalinous pharmaceutical company compared to methylphenidate hydrochloride 10 mg sample of Novartis company in Switzerland on healthy volunteers
Design
The present clinical trial includes the study of the bioequivalence of methylphenidate hydrochloride 10 mg tablets of Jalinous Pharmaceutical Company of Iran in comparison with the sample of methylphenidate hydrochloride 10 mg of Novartis Company of Switzerland, after administration to 24 healthy human volunteers, two intervention administered to one group, in a cross-over manner. It is not blinded and non-randomized.
Settings and conduct
The study is carried out at Nik Azma Pars Alborz company located in Mahdasht Karaj. The blinded cross-over study includes two stages (oral consumption of one 10 mg methylphenidate hydrochloride tablet per study and 2 times in total) with a one-week washout period on 24 fasting healthy volunteers. Then the obtained blood samples are determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy volunteers; Age between 18 and 55 years; non smoker;
Exclusion criteria: candidates with blood pressure less than 90 on 60 mm Hg or higher than 140 on 90 mm Hg.
Intervention groups
The study includes two stages as intervention 1: including oral consumption of methylphenidate hydrochloride 10 mg tablets of Jalinous pharmaceutical company in Iran and intervention 2: taking methylphenidate hydrochloride 10 mg tablets of Novartis company in Switzerland. This study will be repeated on fasting volunteers in a cross-sectional manner with an interval of one week.
Main outcome variables
The maximum plasma concentration of methylphenidate hydrochloride
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057495N15
Registration date:2024-04-13, 1403/01/25
Registration timing:prospective
Last update:2024-04-13, 1403/01/25
Update count:0
Registration date
2024-04-13, 1403/01/25
Registrant information
Name
Monireh Jalalipour
Name of organization / entity
Nikazma Pars Alborz company
Country
Iran (Islamic Republic of)
Phone
+98 26 3731 8748
Email address
info@naplab.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of methylphenidate hydrochloride 10 mg tablet of Jalinous pharmaceutical company compared to methylphenidate hydrochloride 10 mg sample of Novartis company in Switzerland on healthy volunteers
Public title
Bioequivalence study of methylphenidate hydrochloride 10 mg tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteer between 18 and 55 years old.
Body mass index less than 30 kg per square meter.
All candidates must be non-smokers.
Exclusion criteria:
Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg.
Consumption of any drug, alcohol or tobacco within 2 weeks before receiving the drug.
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:
34
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Randomization (investigator's opinion)
Not 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
Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences
Street address
Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Tehran University of Medical Sciences, Porsina Street
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-04-06, 1403/01/18
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.009
Health conditions studied
1
Description of health condition studied
---
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The maximum plasma concentration of methylphenidate hydrochloride
Timepoint
before taking the drug and: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 10 hours after taking the medicine
Method of measurement
Liquid chromatography-mass spectrometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: includes the oral intake of methylphenidate hydrochloride tablets of 10 mg from Iran Jalinous Pharmaceutical Company on 24 fasting healthy volunteers. 5 ml of blood are taken from the volunteers at time intervals before taking the drug and: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 10 hours after taking the drug. The cross-over study consists of two phases (oral administration of one methylphenidate hydrochloride tablet of 10 mg per study and 2 times in total) with a one-week washout period (when the drug is completely removed from your blood). The plasma concentration of methylphenidate hydrochloride is determined by liquid chromatography-mass spectrometry method.
Category
Other
2
Description
Intervention group 2: includes the oral intake of methylphenidate hydrochloride tablets of 10 mg of Novartis company in Switzerlandon on 24 fasting healthy volunteers. 5 ml of blood are taken from the volunteers at time intervals before taking the drug and: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 10 hours after taking the drug. The cross-over study consists of two phases (oral administration of one methylphenidate hydrochloride tablet of 10 mg per study and 2 times in total) with a one-week washout period (when the drug is completely removed from your blood). The plasma concentration of methylphenidate hydrochloride is determined by liquid chromatography-mass spectrometry method.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nik Azma Pars Alborz Laboratory
Full name of responsible person
Monireh Jalalipour
Street address
No. 419, Azadegan Square, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jalinous Pharmaceutical Company
Full name of responsible person
Atieh Amirpour
Street address
No. 18, 23rd St.,Kilometer 10 of Karaj special road
City
Tehran
Province
Tehran
Postal code
1399833611
Phone
+98 21 4454 3351
Email
info@jalinous.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jalinous 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
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Azadegan Square, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Azadegan Square, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Person responsible for updating data
Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Azadegan Squar, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available