Bioequivalence study of 100 mg doxycycline delayed-release capsules manufactured by Behshad Daroo company with reference product manufactured by Avet (Heritage)
The bioequivalence of Behshad Darou's 100 mg delayed-release Doxycycline capsule is being assessed in comparison to the reference product made by Avet (Heritage) company.
Design
This study is conducted as a crossover study during 2 days with a 2 week washout period.
Settings and conduct
After administration of drug fasting condition, blood sampling is performed from the time of administration to 72 hours after drug administration, according to the schedule provided. Blood samples are transferred to heparinized tubes and stored in ice until centrifuged. The resulting plasma is stored at -80 ° C until analysis.
Participants/Inclusion and exclusion criteria
healthy Volunteers, 18-40 years, Body mass index of 18.5-30 kg/cm3 No history of allergy to tetracycline antibiotics and excipients used in the products formulations No history of diseases affecting the pharmacokinetic processes of the drug No administration of potent cytochrome p450 inhibitors 4 weeks before start of the study No history of smoking, alcohol and narcotics use Not being pregnant or breastfeeding Adherence to study criteria based on ethical commitment and informed consent Absence of severe liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)
Intervention groups
The first group will receive 2 capsules of the reference brand medication in the first period of the study and 2 capsules of the Iranian generic medication in the second period.
The second group will receive 2 capsules of the Iranian generic medication in the first period and 2 capsules of the reference brand medication in the second period.
Main outcome variables
Cmax-tmax-AUC0-t
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230629058615N1
Registration date:2023-09-24, 1402/07/02
Registration timing:prospective
Last update:2023-09-24, 1402/07/02
Update count:0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Amir Rezazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 729 8761
Email address
rezazadeh.am@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of 100 mg doxycycline delayed-release capsules manufactured by Behshad Daroo company with reference product manufactured by Avet (Heritage)
Public title
bioequivalence study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteer’s health (based on the results of physical examinations and clinical tests)
Volunteer’s health (based on the results of physical examinations and clinical tests)
Body mass index of 18.5-30 kg/m2
No history of allergy to tetracycline antibiotics and excipients used in the products formulations
No administration of potent cytochrome p450 inhibitors 4 weeks before start of the study
No history of diseases affecting the pharmacokinetic processes of the drug
No history of smoking, alcohol and narcotics use
Not being pregnant or breastfeeding
Adherence to study criteria based on ethical commitment and informed consent
Absence of severe liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)
Exclusion criteria:
Pregnancy
Tobacco or alcohol use, acute or chronic
Failure to obtain any of the mentioned items regarding health tests
Drug administration before and during the study
Lack of adherence to study criteria
Incidence of adverse reactions
liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)
Age
From 18 years old to 40 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
In this study, 24 volunteers will be divided into two groups. The first group will receive the brand medication, and the second group will receive the generic medication. The Grouping will be done in a randomized manner:
In this study, 24 medication, including 12 generic medication and 12 brand medication, will be randomly assigned to patients using a random code (including numbers and letters). After coding the drugs, each code will be randomly assigned to an individual using a random command.
Due to the crossover design of the study, in the second period, each patient will receive the other type of drug.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients will not be informed about the type of drug they are receiving.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of pharmacy and pharmaceutical sciences, Tehran Medical Sciences, Islami
Street address
Islamic Azad University of Medical Sciences, Shariati St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2022-03-10, 1400/12/19
Ethics committee reference number
IR.IAU.PS.REC.1399.238
Health conditions studied
1
Description of health condition studied
The study will be performed on healthy volunteers.