Bioequivalence study of Tacrolimus 1mg ( Taclirus) manufactured by Alborz Zagros company versus originator brand in healthy volunteers in fasting condition
Bioequivalence Study of Tacrolimus 1mg manufactured by Alborz Zagros company versus originator brand (Prograf) manufactured by Astellas company
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct
The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (72h). The interval between these two periods is 2 weeks. In the first round of the study, the candidates divide into two groups and the first group receives a test capsule and the second group receives a brand capsule. Blood samples are collected immediately before and after drug administration by volunteers. Then, plasma separation and drug extraction are done and samples are ready for analysis.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcoholism and Narcoticism, History of allergy to Tacrolimus
Intervention groups
Intervention group 1: Program 1mg capsule as a reference
Intervention group 2: Taclirus 1mg capsule as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration, Half-life of drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047902N10
Registration date:2021-11-18, 1400/08/27
Registration timing:prospective
Last update:2021-11-18, 1400/08/27
Update count:1
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
Elham Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 5196
Email address
ghasemian@zistdaru.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Tacrolimus 1mg ( Taclirus) manufactured by Alborz Zagros company versus originator brand in healthy volunteers in fasting condition
Public title
Bioequivalence study of Tacrolimus 1mg
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to Tacrolimus
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
19
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. The balls are then removed randomly from the container. The first 12 no.s are considered as (first sequence: Alborz Zagros's medicine ) and the second 12 no.s are considered as (second sequence: originator brand recipient). The volunteers don't have any information about taking the test drug or brand drug
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Alborz Zagros's Tacrolimus and Originator brand's capsules are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences