In-vivo Bioequivalence Study of Pimozide 4 mg tablets of The Test Drug (Porica®,Tadbir Kalaye jam pharmaceutical co, Iran) in Compared with The Reference Drug (Orap® 4 mg, Janssen. Belguim) In Iranian Healthy Volunteers
In-vivo Bioequivalence Study of Pimozide 4 mg tablets of The Test Drug (Porica®,Tadbir Kalaye jam pharmaceutical co, Iran)
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization.
Settings and conduct
The study is a single-blinded (Volunteers), cross-over and fast, and on two series of healthy volunteers. The study will be done in two periods (144h). The interval between these two periods is 1 week. In the first round of the study, the candidates were divided into two groups the first group received a test tablet and the second group received a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. Sampling is performed in Asr nano company in Tehran.
Participants/Inclusion and exclusion criteria
General Health (Liver, Heart, and Kidney), Body Mass Index (18-30), informed consent, Age (18-55years old)
Intervention groups
Intervention group 1: (Orap® 4 mg, Janssen. Belguim) tablets as a reference Intervention group 2: (Porica®,Tadbir Kalaye jam pharmaceutical co, Iran) as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240803062623N8
Registration date:2024-10-29, 1403/08/08
Registration timing:prospective
Last update:2024-10-29, 1403/08/08
Update count:0
Registration date
2024-10-29, 1403/08/08
Registrant information
Name
Mohammad Ali Karkhaneh Yousefi
Name of organization / entity
Tadbir Kalaye Jam co.
Country
Iran (Islamic Republic of)
Phone
+98 21 8866 8700
Email address
yousefi@tadbirkala.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-30, 1403/10/10
Expected recruitment end date
2026-01-30, 1404/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In-vivo Bioequivalence Study of Pimozide 4 mg tablets of The Test Drug (Porica®,Tadbir Kalaye jam pharmaceutical co, Iran) in Compared with The Reference Drug (Orap® 4 mg, Janssen. Belguim) In Iranian Healthy Volunteers
Public title
In-vivo Bioequivalence Study of Pimozide 4 mg tablets of The Test Drug (Porica®,Tadbir Kalaye jam pharmaceutical co, Iran)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-30)
Informed consent
Age (18-55years old)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to Pimozide
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:
40
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 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: test 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). Test and Originator brand's tablets 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
Ethics committee of Tehran University of Medical Sciences
Street address
5th floor,No. 60, Mollasadra Ave, Vanak Sq
City
Tehran
Province
Tehran
Postal code
1435793175
Approval date
2023-01-22, 1401/11/02
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.104
Health conditions studied
1
Description of health condition studied
This study is performed on healthy volunteers and drug concentration in plasma is determined.
Time to reach the maximum drug concentration in plasma is recorded.
2
Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time
Intervention groups
1
Description
Intervention group: single dose, one oral tablets (Orap® 4 mg, Janssen. Belguim) as a reference product. after washout period, the volunteers received Pimozide 4 mg (Porica®,Tadbir Kalaye jam pharmaceutical co, Iran)
Category
Treatment - Drugs
2
Description
Intervention group: Single dose, one oral Pimozide 4 mg tablet (Porica® Tadbir Kalaye jam pharmaceutical co, Iran) as test product. after washout period, the volunteers received (Orap® 4 mg, Janssen. Belguim)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Asr Nano company
Full name of responsible person
Mohammad Ali Karkhaneh Yousefi
Street address
Asr Nano company, Polymer research institute, Pajuhesh boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۹۷۷۱۳۱۱۶
Phone
+98 21 4478 7091
Email
yousefi@tadbirkala.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tadbir Kala Jam
Full name of responsible person
Mohammad Ali Karkhane Yosefi
Street address
5th floor, No.60, Mollasadra Ave، Vanak squre
City
Tehran
Province
Tehran
Postal code
1435793175
Phone
+98 21 8866 8700
Fax
+98 21 8866 8710
Email
n.mohammadi@tadbirkala.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?