Bioequivalence study of two Lisdexamfetamine 70 mg capsule manufactured by tadbir kalaye jam 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 (Volunteers), cross-over and fast, and on two series of healthy volunteers. The study will be done in two periods (6h). 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 capsule and the second group received a brand capsule. 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: Elvanse 70 mg capsule as a reference Intervention group 2: Lisdexamfetamine 70 mg capsule 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:IRCT20240803062623N9
Registration date:2024-10-31, 1403/08/10
Registration timing:prospective
Last update:2024-10-31, 1403/08/10
Update count:0
Registration date
2024-10-31, 1403/08/10
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
recruiting
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-12-13, 1404/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of two Lisdexamfetamine 70 mg capsule manufactured by tadbir kalaye jam company in comparison with Elvanse 70 mg capsule
Public title
Bioequivalence study of two Lisdexamfetamine 70 mg capsule manufactured by tadbir kalaye jam company
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 Lisdexamfetamine
Age
From 18 years old to 55 years old
Gender
Male
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:
24
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People in the mentioned age group are invited to participate through the advertisement. 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. are considered as (first sequence: test medicine ) and the second 12 No. 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
Research Ethics committee of National Institute for Medical Research Development
Street address
5th floor,N o. 60, Mollasadra Ave, Vanak Sq
City
Tehran
Province
Tehran
Postal code
1435793175
Approval date
2024-08-21, 1403/05/31
Ethics committee reference number
IR.NIMAD.REC.1403.080
Health conditions studied
1
Description of health condition studied
This study is performed on healthy volunteers and drug concentration in plasma is determined.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 4, 5, 6 h after drug administration
Method of measurement
Liquid chromatography (mass spectrometry)
Secondary outcomes
1
Description
Time to reach maximum plasma concentration
Timepoint
After intervention
Method of measurement
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 Elvanse 70 mg capsule as a reference product. after washout period, the volunteers received Lisdexamfetamine 70 mg capsule manufactured by tadbir kalaye jam company
Category
Treatment - Drugs
2
Description
Intervention group: Single dose, one oral Lisdexamfetamine 70 mg capsule manufactured by tadbir kalaye jam company as test product. after washout period, the volunteers received Elvanse 70 mg capsule
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 7032
Email
yousefi@tadbirkala.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tadbir Kala Jam
Full name of responsible person
Mohammad Ali Karkhaneh 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?
Yes
Title of funding source
Tadbir Kala Jam
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tadbir Kalaye Jam co.
Full name of responsible person
Mohammad Ali Karkhaneh Yousefi
Position
Medical Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 60 , Mollasadra Ave, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435793175
Phone
+98 21 8866 8700
Fax
+98 21 8866 8710
Email
yousefi@tadbirkala.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tadbir Kalaye Jam co.
Full name of responsible person
Mohammad Ali Karkhaneh Yousefi
Position
Medical Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 60 , Mollasadra Ave., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435793175
Phone
+98 21 8866 8700
Fax
+98 21 8866 8710
Email
yousefi@tadbirkala.com
Person responsible for updating data
Contact
Name of organization / entity
Tadbir Kalaye Jam co.
Full name of responsible person
Mohammad Ali Karkhaneh Yousefi
Position
Medical Manager
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 60 , Mollasadra Ave., Vanak Square
City
Tehran
Province
Tehran
Postal code
1435793175
Phone
+98 21 8866 8700
Fax
+98 21 8866 8710
Email
yousefi@tadbirkala.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
These data are as secure between researchers and related industries.