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Bioequivalence Study of sustained release Diclofenac 100 mg capsule manufactured by Tasinm Pharmaceutical and and Diclofenac 100 mg capsule menufactured by Ratio pharm in 24 Healthy volunteers under fasting condition

Protocol summary

Study aim
Comparison of the bioavailability of Diclofenac sustained release capsules after a single dose of 100 mg, manufactured by Tasnim Pharmaceutical and Ratio pharm.
Design
The study is a cross-over double-blind study. 24 healthy volunteers using the random option in excel software will be assigned a code, and depending on the code, the first half will receive the test, and the second half will receive reference drugs. In each phase of the study, 12 blood samples will be received from the individual.
Settings and conduct
On the day of sampling, after 10 hours of fasting, the volunteers come to Kharazmi Plasma Center in Islamshahr ( No. 13, 1st Shehamat Alley, Ali Ibn Abitalib St., Namaz Square,) and receive one capsule of the test or reference drug with 240 ml of water and blood samples are taken at 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hours after drug administration, after plasma separation, the samples were transferred to a -70 freezer and finally the concentration of drug in plasma will be determined according to the LCMSMS method.After a one-week wash out period, the process of drug administration is done vise versa.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects, Body weight must be ≥50 kg and <100 kg, with a body mass index (BMI) >18 but <33.Laboratory parameter values must fall within the normal range Exclusion criteria: history of allergic reaction to Diclofenac . Smokers or user of tobacco products.
Intervention groups
Comparing the blood concentration of Diclofenac of Tasnim Pharmaceutical and Ratio pharm.
Main outcome variables
Plasma concentration caused by test and reference drug

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220209053979N12
Registration date: 2023-12-07, 1402/09/16
Registration timing: prospective

Last update: 2023-12-07, 1402/09/16
Update count: 0
Registration date
2023-12-07, 1402/09/16
Registrant information
Name
Roya Talari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8880 0892
Email address
talari_r@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2023-12-28, 1402/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence Study of sustained release Diclofenac 100 mg capsule manufactured by Tasinm Pharmaceutical and and Diclofenac 100 mg capsule menufactured by Ratio pharm in 24 Healthy volunteers under fasting condition
Public title
Bioequivalence of sustained release Diclofenac 100 mg capsule manufactured by Tasinm Pharmaceutical and Diclofenac 100 mg capsule manufactured by Ratio pharm
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy male or female volunteers Body mass index (BMI) between 18 - 30 Volunteers who are willing to sign an informed consent form
Exclusion criteria:
History of allergic reaction to memantin or formulation components Taking any type of medicine in the 14 days before the start of the study Participation in any type of clinical study in the last month
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 24
More than 1 sample in each individual
Number of samples in each individual: 12
5 mililitr blood sample is taken from each volunteers
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug (test or reference drug) is removed from the original packaging the day before the study and packaged in small disposable containers. Therefore, it is not in the original packaging and also the visual appearance and size of the test and reference capsules are the same , none of the volunteer nor the prescriber know which drug is being administered. The relevant code is also written on the sample collecting tubes of each volunteer, neither the analyzer knows the test or reference drug sample is analyzing.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, 16 Azar St.,
City
Tehran
Province
Tehran
Postal code
1417713135
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
IR. TUMS. TIPS. REC. 1402. 11

Health conditions studied

1

Description of health condition studied
A crossover bioequivalence study in 24 healthy volunteers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plasma concentration time profile, maximum plasma concentration, AUC
Timepoint
0 ، 1، 1.5 ، 2 ، 2.5 ، 3، 4، 5، 6 ، 8، 10, 24 h after drug administration.
Method of measurement
Liquid chromatography with mass spectrophotometry

Secondary outcomes

1

Description
Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug.
Timepoint
Same as primary outcome.
Method of measurement
Pharmacokientic parameters are calculated by excel.

Intervention groups

1

Description
Intervention group: Oral administration of one Diclofenac 100 mg capsule manufactured by Tasnim Pharmaceutical to 12 healthy volunteers under fasting condition with 240 ml of water. Then 12 blood samples are taken from volunteers at 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24 hours after drug administration. In the second phase after a wash out period of one week , this group will take Ratio pharm medicine and blood samples are taken at the same times.
Category
Other

2

Description
Intervention group: Oral administration of one Diclofenac 100 mg capsule manufactured by Ratio pharm to 12 healthy volunteers under fasting condition with 240 ml of water. Then 12 blood samples are taken from volunteers at 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24 hours after drug administration. In the second phase after a wash out period of one week , this group take Tasnim Pharmaceutical medicine and blood samples are taken at the same times.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kharazmi plasma center
Full name of responsible person
Sara Solgi
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
City
Islamshahr
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
Info@kpcir.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tasnim Pharmaceutical
Full name of responsible person
Dr. Nami Moghadam
Street address
Tasnim Building, No. 3, 14th East Street, Beyhaqi St., Argentina Square
City
Tehran
Province
Tehran
Postal code
1517615814
Phone
+98 21 8877 2072
Email
info@tasnimpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tasnim Pharmaceutical
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
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
Executer
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
City
Islamshar
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
Executer
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
City
Islamshar
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
Executer
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
City
Islamshar
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.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
The bioequivalence study data is completely confidential and according to the contract with Tasnim Pharmaceutical Company, it should not be published anywhere.
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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