To evaluate the pharmacokinetic parameters obtained after the single oral administration of the drug from either test or reference preparations
Design
This cross-over study will be done on 24 normal subjects. They were randomly allocated into two groups. After overnight fasting, they will receive one tablet from either Reihaneh or So-Se-Pharm pharmaceutical companies on two working days separated by a wash-out period of two weeks. They are not allowed to eat any consumption up to 3 hours at this time will receive a simple breakfast. Blood samples will be collected, at suitable intervals.
Settings and conduct
Kermanshah University of Medical Sciences, Medical Biology Research Center
Participants/Inclusion and exclusion criteria
Healthy volunteers
Intervention groups
Subjects receiving Rihaneh-manufactured drug
Subjects receiving So Se Pharm-manufactured drug
Main outcome variables
Pharmacokinetic parameters include Elimination half-life, Area under the concentration-time curve up to sampling time, Area under the concentration-time curve up to infinity, Maximum concentration and Time to maximum concentration,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110523006565N2
Registration date:2022-02-05, 1400/11/16
Registration timing:prospective
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Gholam Reza Bahrami
Name of organization / entity
Kermanhsah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1428 1562
Email address
gbahrami@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-10, 1400/11/21
Expected recruitment end date
2022-02-24, 1400/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence Study of Ursodeoxycholic acid Tablets manufactured by Raihaneh and So-Se-Pharm Pharmaceutical companies
Public title
Bioequivalence Study of Ursodeoxycholic acid
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent.
Normal findings in the physical examination.
Clinical laboratory values within 10% above or below the laboratory’s stated normal range
To be a non-smoker
Exclusion criteria:
History of hypersensitivity to the study drug or related products
Significant history or presence of gastrointestinal, liver or kidney disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of common medications
Any clinically significant illness during the 4 weeks prior to day 1 of this study
Maintenance therapy with any drug, or history of drug dependence, alcohol abuse, or serious neurological or psychological disease
Use of any systemic medication (including OTC preparations) within 14 days preceding day 1 of this study
HIV and Hepatitis A, B and C positive subjects
Age
From 18 years old to 45 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All the subjects will be received one tablet from either test or reference preparations on two working days separated by a wash-out period of two weeks.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committe of Kermanshah University of Medical Sciences and Health Services