Comparative bioequivalence study of Hydrochlorothiazide 50 mg Tablet of Karen. and APO-HYDRO® of Apotex INC as reference in 24 healthy male under fasting.
This study will be performed to compare the pharmacokinetics and invivo parameters of Hydrochlorothiazide 50 mg Tablet formulation.
Design
Non-blinded, randomized, crossover in vivo bioequivalence study in 24 healthy males under fasting conditions. Block randomization is used.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Noor Research and Development Institute (Tarasht, Tehran). 2 dosing periods will be separated by a 7-day washout period.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Exclusion Criteria: Subjects with a history of known hypersensitivity to hydrochlorothiazide or other sulfonamide drugs, associated acute or chronic infections;
Volunteers who have water and electrolyte disorders, including low blood potassium and sodium, history of diarrhea or vomiting, headache, muscle cramps or weakness in the past two weeks;
Intervention groups
Intervention group 1: Hydrochlorothiazide 50 mg Tablet, produced by Karen. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention group 2: APO-HYDRO 50 mg Tablet, produced by Apotex INC is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Main outcome variables
Peak Plasma Concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180620040164N51
Registration date:2023-10-21, 1402/07/29
Registration timing:prospective
Last update:2023-10-21, 1402/07/29
Update count:0
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
Behzad Montaha Sangari
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-16, 1402/08/25
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Hydrochlorothiazide 50 mg Tablet of Karen. and APO-HYDRO® of Apotex INC as reference in 24 healthy male under fasting.
Public title
Comparative in vivo evaluation of 2 Hydrochlorothiazide 50 mg Tablet formulations.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteers
Between 18 – 45 years of age and
Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18 and 30 (inclusive), calculated as kg/m2.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Subjects with normal vital signs.
Exclusion criteria:
Subjects with a history of known hypersensitivity to hydrochlorothiazide or other sulfonamide drugs, associated acute or chronic infections;
Volunteers who have water and electrolyte disorders, including low blood potassium and sodium, history of diarrhea or vomiting, headache, muscle cramps or weakness in the past two weeks;
blood pressure in standing position and after at least 5 minutes of rest, systole less than 100 or more than 140 mmHg and diastole less than 60 or more than 90 mmHg);
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period;
volunteers with a history of difficulty with donating blood;
donation of more than 500 ml blood within 7 days prior to the start of the study;
Age
From 18 years old to 45 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer numbers (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer.
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
Ethics Committee,School of Pharmacy,Nursing&Midwifery-Shahid Beheshti University of medical sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2023-10-09, 1402/07/17
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.130
Health conditions studied
1
Description of health condition studied
Essential (primary) hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 72 hours after intervention.
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Secondary outcomes
1
Description
AUC (Area Under the Concentration-Time Curve)
Timepoint
17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 72 hours after intervention.
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Intervention groups
1
Description
Intervention group 1: Hydrochlorothiazide 50 mg Tablet , produced by Karen. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 2 will be given to these subjects.
Category
Treatment - Drugs
2
Description
Intervention group 2: APO-HYDRO 50 mg tablet, produced by Apotex INC is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 1 will be given to these subjects.