Comparative bioequivalency study (pharmacokinetics- pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic prostate cancer Volunteers
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Protocol summary
Evaluation of the effect of variopeptyl® 11.25 mg extended-release injection drug made by Varian Pharmed company in comparison with diphereline ® 11.25 mg drug made by Ipsen company, based on the reduction of sex hormone levels in volunteers with non-metastatic prostate cancer.
Evaluation of pharmacokinetic parameters based on measurement of serum triptorelin concentration, Evaluation of pharmacodynamic parameters based on measurement of decreased sex hormone levels (reduction of serum testosterone level to castration level) of patients with non-metastatic prostate cancer.
Evaluation of the effect of variopeptyl® 11.25 mg extended-release injection drug made by Varian Pharmed company in comparison with diphereline ® 11.25 mg drug made by Ipsen company,pharmacokinetic parameters based on the reductionmeasurement of serum triptorelin concentration, Evaluation of pharmacodynamic parameters based on measurement of decreased sex hormone levels in volunteers(reduction of serum testosterone level to castration level) of patients with non-metastatic prostate cancer.
• بررسی اثر داروی تزریقی آهسته رهش واریوپپتیل® 11.25 میلی گرم ساخت شرکت واریان فارمد در مقایسه با داروی دیفرلین® 11.25 میلی گرم ساخت شرکت ایپسن در داوطلبان بیمار مبتلا به سرطان پروستات غیرمتاستاتیک، براساس کاهش سطح هورمونهای جنسی داوطلبان بیمار مبتلا به سرطان پروستات غیرمتاستاتیک.
• بررسی پارامترهای فارماکوکینتیک براساس اندازه گیری غلظت سرمی تریپتورلین، بررسی پارامترهای فارماکودینامیک براساس اندازه گیری کاهش سطح هورمونهای جنسی ( کاهش سطح سرمی تستسترون به سطح اختگی)داوطلبان بیمار مبتلا به سرطان پروستات غیرمتاستاتیک
• بررسی اثر داروی تزریقی آهسته رهش واریوپپتیل® 11.25 میلی گرم ساخت شرکت واریان فارمد در مقایسه با داروی دیفرلین® 11.25 میلی گرم ساخت شرکت ایپسن در داوطلبانپارامترهای فارماکوکینتیک براساس اندازه گیری غلظت سرمی تریپتورلین، بررسی پارامترهای فارماکودینامیک براساس اندازه گیری کاهش سطح هورمونهای جنسی ( کاهش سطح سرمی تستسترون به سطح اختگی)داوطلبان بیمار مبتلا به سرطان پروستات غیرمتاستاتیک، براساس کاهش سطح هورمونهای جنسی داوطلبان بیمار مبتلا به سرطان پروستات غیرمتاستاتیک.
Testosterone serum level
measurement of serum triptorelin concentration
Testosteronemeasurement of serum leveltriptorelin concentration
سطح سرمی تستسترون
اندازه گیری غلظت سرمی تریپتورلین
سطحاندازه گیری غلظت سرمی تستسترونتریپتورلین
Primary outcomes
#1
Measurement of serum testosterone
Measurement of triptorelin concentration
Measurement of serum testosteronetriptorelin concentration
اندازه گیری سطح سرمی تستسترون
اندازه گیری سطح سرمی تریپتورلین
اندازه گیری سطح سرمی تستسترونتریپتورلین
RIA
[D-Trp6]-LHRH
RIA[D-Trp6]-LHRH
رادیو ایمونواسی
ایمونواسی
رادیو ایمونواسی
Secondary outcomes
#1
empty
Measurement of serum testosterone
Measurement of serum testosterone
empty
غلظت سرمی تستسترون
غلظت سرمی تستسترون
empty
At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
empty
ابتدای مطالعه(قبل از شروع مداخله) و در طی 24 ساعت بستری در بیمارستان ، 1، 2، 4، 6، 8، 12 ساعت پس از تجویز دارو و 2، 3، 7، 14، 21، 28، 31، 35، 42، 60، 65، 75، 80، 84، 90 روز بعدا از تجویز دارو اندازه گیری خواهد شد.
ابتدای مطالعه(قبل از شروع مداخله) و در طی 24 ساعت بستری در بیمارستان ، 1، 2، 4، 6، 8، 12 ساعت پس از تجویز دارو و 2، 3، 7، 14، 21، 28، 31، 35، 42، 60، 65، 75، 80، 84، 90 روز بعدا از تجویز دارو اندازه گیری خواهد شد.
empty
RIA
RIA
empty
رادیوایمونواسی
رادیوایمونواسی
Protocol summary
Study aim
Evaluation of pharmacokinetic parameters based on measurement of serum triptorelin concentration, Evaluation of pharmacodynamic parameters based on measurement of decreased sex hormone levels (reduction of serum testosterone level to castration level) of patients with non-metastatic prostate cancer.
Design
This clinical trial is a bioequivalence study, randomized, double-armed, double-blind, parallel, with a 1: 1 ratio of volunteers.
Settings and conduct
This clinical trial at Isfahan Poursina Research Center begins to accept volunteer patients. This study is double-blind and the patient and the principal investigator are unaware of the type of prescription intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Men between the ages of 50 and 70
• patient with non-metastatic prostate cancer whose disease has been diagnosed based on examination and paraclinical procedures.
• No cardiovascular, cerebral, renal or hepatic problems.
• No history of hormone use, immunosuppressive drugs in the last 2 months
• No immune system diseases such as AIDS and .MS
• Able and willing to sign informed consent form;
Exclusion criteria:
• Sensitivity to drugs, especially GnRH-A
Previous history of chemotherapy
• Metastatic prostate cancer
• Other diseases
Intervention groups
All volunteers are randomly divided into two groups after definitive confirmation of non-metastatic prostate cancer and one group will receive 11.25 mg of extended-release injectable variopeptyl and the other group will receive 11.25 mg of injectable extended-release drug diphererline.
Main outcome variables
measurement of serum triptorelin concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170225032759N3
Registration date:2021-04-06, 1400/01/17
Registration timing:prospective
Last update:2021-12-19, 1400/09/28
Update count:3
Registration date
2021-04-06, 1400/01/17
Registrant information
Name
Amir Mansour Jalali Nadooshan
Name of organization / entity
Varian Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 2485 2480
Email address
a.jalali@varianpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalency study (pharmacokinetics- pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic prostate cancer Volunteers
Public title
Comparative bioequivalency study (pharmacokinetics-pharmacodynamics) of Variopeptyl® 11.25 mg and Diphereline® 11.25 mg in Patients with non-metastatic prostate cancer Volunteers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Men between the ages of 50 and 70
• patient with non-metastatic prostate cancer whose disease has been diagnosed based on examination and paraclinical procedures.
• Without cardiovascular, cerebral, renal and liver problems.
• No history of hormone use, immunosuppressive drugs in the last 2 months
• No immune system diseases such as AIDS and MS
• Able and willing to sign informed consent form
Exclusion criteria:
• Sensitivity to drugs, especially GnRH-A
• Previous history of chemotherapy
• Metastatic prostate cancer
• Other diseases
Age
From 50 years old to 70 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on randomized classification blocks.
The randomization sequence will be created using the RandBETWEEN in Excel program.
Blinding (investigator's opinion)
Double blinded
Blinding description
People who in this study will be unaware of the type of intervention prescribed to patients participating in the study are:
•Patient
• Principal Investigator (Physician)
The person who is aware of the type of intervention prescribed to patients in this study is the central staff that patients will refer to during the previous coordination, and based on the random allocation list, one of the two interventions will be prescribed for them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.MUI.MED.REC.1399.1142
Health conditions studied
1
Description of health condition studied
non-metastatic prostate cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of triptorelin concentration
Timepoint
at the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
Method of measurement
[D-Trp6]-LHRH
Secondary outcomes
1
Description
Measurement of PSA level
Timepoint
At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
Method of measurement
PSA tumor marker (ng/ml)
2
Description
Measurement of serum testosterone
Timepoint
At the beginning of study, During 24 hours of hospitalization, 1, 2, 4, 6, 8, 12 hours after drug administration and 2, 3, 7, 14, 21, 28, 31, 35, 42, 60, 65, 75, 80, 84, 90 days will be measured after drug administration.
Method of measurement
RIA
Intervention groups
1
Description
Intervention group: ِDiphereline 11.25 mg single dose for 3 months
Category
Treatment - Drugs
2
Description
Intervention group: Variopeptyl 11.25 mg single dose for 3 months