Randomized, single-dose, crossover comparative bioequivalence study of the Atorvastatin 40 mg tablets produced by Daana pharmaceutical Co versus Lipitor® (Pfizer company) in 24 healthy males under fasting conditions
To demonstrate bioequivalence of single dose test formulation of Daana Atorvastatin 40 mg tablets versus Lipitor®(Pfizer Co.)
Design
Single dose, randomized and crossover bioequivalence study of Atorvastatin 40 mg tablets by Daana Co. with Lipitor® (Pfizer Co.) in 24 healthy male in two groups under fasting condition.
Settings and conduct
Study place: Drug Applied Research Center affiliated to Tabriz University of Medical Science. Place for Blood and plasma sample analysis: Imam Reza Medical Research and Trainning Hospital. 24 healthy male volunteers will receive each of two test or reference Atorvastatin 40 mg tablets in random sequence according to the randomization schedule. The interval between receiving the medicine (washout period) is 7 days. Blood samples of volunteers at 0 (before dosing), 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 6، 8، 10, 12، 24 and 48 hour after dosing will be collected.
Participants/Inclusion and exclusion criteria
The weight limit for each volunteer is between 60 and 100 kg. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed. Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Atorvastatin or any ingredients. Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily.
Intervention groups
Intervention group 1: In this group, volunteers are given a single oral dose of Atorvastatin 40 mg tablet of Daana Pharmaceutical Co.. Intervention group 2: In this group, volunteers are given a single oral dose of Lipitor® tablets of Pfizer company. After the washout period, the volunteers are placed in the opposite group. In fact, every single volunteers is used as control for himself.
Main outcome variables
Peak Plasma Concentration (Cmax); Area under the concentration-time curve (AUC).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200407046981N16
Registration date:2021-09-14, 1400/06/23
Registration timing:prospective
Last update:2021-09-14, 1400/06/23
Update count:0
Registration date
2021-09-14, 1400/06/23
Registrant information
Name
Fatima Molavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 2700
Email address
molavif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2021-12-01, 1400/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, single-dose, crossover comparative bioequivalence study of the Atorvastatin 40 mg tablets produced by Daana pharmaceutical Co versus Lipitor® (Pfizer company) in 24 healthy males under fasting conditions
Public title
Study of absorption and elimination rate of Atorvastatin 40 mg tablets in comparison with standard tablets of Atorvastatin (Lipitor®).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The weight limit for each volunteer is between 60 and 100 kg.
All volunteers must be non-smokers.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Exclusion criteria:
Known hypersensitivity or idiosyncratic reaction to Atorvastatin or any ingredients.
Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg.
Regular smoker who smokes more than ten cigarettes daily.
Taking any medicine during two week before dosing.
Age
From 18 years old to 60 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
First, a table of random numbers from 1 to 24 is created. The table numbers are assigned to individuals in the order in which the candidates enter the list on the day of the experiment, and the candidates in two groups with numbers 1-12 and numbers 13-24 will receive reference and test medicine, respectively.
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 of Tabriz University of Medical Science
Street address
Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran
At 0 (before dosing), 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 6، 8، 10، 12، 24 and 48 hour after dosing
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS
Intervention groups
1
Description
Intervention group 1: In this group, volunteers are given a single oral dose of Atorvastatin 40 mg tablet produced by Daana Co. (Domestic). After the washout period, the volunteers are placed in the Intervention group 2. In fact, every single volunteers is used as control for himself.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, volunteers are given a single oral dose of Atorvastatin 40 mg tablets (Lipitor), produced by Pfizer Company (Brand). After the washout period, the volunteers are placed in the Intervention group 1. In fact, every single volunteers is used as control for himself.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Drug Applied Research Center
Full name of responsible person
Dr Hamed Hamishehkar
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Fax
+98 41 3336 7914
Email
hamishehkar.hamed@gmail.com
Web page address
https://darc.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Daana pharmaceutical company
Full name of responsible person
Ahmad Kharazi
Street address
East Azerbaijan Province, Basmenj, Tehran - Tabriz Fwy
City
Tabriz
Province
East Azarbaijan
Postal code
5495151673
Phone
+98 41 3630 0586
Fax
+98 41 3630 0591
Email
name@domain.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Daana pharmaceutical company
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamed Hamishehkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Email
Hamishehkar.hamed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Emami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7111
Fax
+98 31 3668 0011
Email
Emami@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatima Molavi
Position
PhD student of Pharmaceutics
Latest degree
Medical doctor
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 2700
Fax
Email
Molavif@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available