Randomized, single-dose, crossover comparative bioavailability study of the Marhamdarou zolpidem versus Stilnoct (Sanofi Company) in 24 healthy males under fasting conditions
To demonstrate bioequivalence of single dose test formulation of Marhamdarou zolpidem 10 mg tablet with reference stilnoct 10 mg tablet (Sanofi Co.) in healthy male subjects under fasting condition
Design
Bioequivalence crossover study to compare single-dose Zolpidem 10 mg tablets manufactured by Marhamdarou company and single-dose Stilnoct 10 mg tablets manufactured by Sanofi company in 24 healthy male under fasting condition.
Settings and conduct
Study place: diabetes clinic affiliated to Shahid Beheshti endocrine research institute.
Place for Blood and plasma sample analysis: TAVAN institute.
Twenty four healthy male volunteers received each of two test or reference Zolpidem tablets in random sequence according to the randomization schedule. Receiving drug periods were 7 day apart from each other and after the washout period, subjects received the other product. Blood samples were taken from all participants before receiving the drug and 12 hours after that at determined time points for pharmacokinetic evaluations.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy male subjects in the age range of 18-55 years old; subjects with BMI (Body Mass Index) of 18.5-30. Exclusion criteria: subjects with medical history of disease; subjects with unusual measures in blood tests and clinical examination; subjects with physical or psychological dependence to narcotics.
Intervention groups
Intervention group 1 (Test): Zolpidem 10 mg Tablet, produced by Marham Darou is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Control group (Reference): Stilnoct 10 mg Tablet (produced by Sanofi Co.) is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Main outcome variables
Peak Plasma Concentration (Cmax); Time of maximum measured plasma concentration (Tmax)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180620040164N1
Registration date:2018-12-06, 1397/09/15
Registration timing:retrospective
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
Behzad Montaha Sangari
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-18, 1396/10/28
Expected recruitment end date
2018-01-25, 1396/11/05
Actual recruitment start date
2018-01-18, 1396/10/28
Actual recruitment end date
2018-01-25, 1396/11/05
Trial completion date
2018-08-01, 1397/05/10
Scientific title
Randomized, single-dose, crossover comparative bioavailability study of the Marhamdarou zolpidem versus Stilnoct (Sanofi Company) in 24 healthy males under fasting conditions
Public title
Bioequivalence study of zolpidem 10 mg tablet in 24 healthy male under fasting conditions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
healthy subjects with BMI 18.5-30 kg/m2
Not having a history of any significant disease or any abnormal finding in laboratory examination or during physical examination
Not physical or psychological dependence to narcotics
Exclusion criteria:
Known hypersensitivity to zolpidem or any ingredients.
Obstructive sleep apnea
Ingestion of a medicine (even herbal medicines), drugs for abuse or cigarette at any time within 7 days before dosing in Period-I (before the beginning of the study)
History of any problem in blood donation
Consumption of alcohol, grapefruit juice or caffeinated drinks 24 hours prior to the drug administration.
Myasthenia gravis
Severe hepatic insufficiency
Acute and/or severe respiratory depression
Any diseases that interacting with ADME (Absorption, Distribution, Metabolism & Excretion) procedures
Psychotic illnesses
Blood loss (>200 ml) during recent 60 days
Age
From 18 years old to 55 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of taking test or reference product for each volunteer was determined according to the randomization schedule. The randomization schedule was prepared according to volunteer's allocated number. This number was allocated according to their entrance to volunteers' list in screening day
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 Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Builing No.2, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak
City
tehran
Province
Tehran
Postal code
19839-63113
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.SBMU.REC.1396.227
Health conditions studied
1
Description of health condition studied
comparative bioequivalence study of zolpidem 10 mg tablets of Marhamdarou Co. and Sanofi Co.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
During 2 months after intervention
Method of measurement
using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Secondary outcomes
1
Description
Time of maximum measured plasma concentration (Tmax)
Timepoint
During 2 months after intervention
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).
Intervention groups
1
Description
Intervention group (Test): Zolpidem 10 mg Tablet, produced by Marham Darou is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
2
Description
Control group (Reference): Stilnoct 10 mg Tablet (produced by Sanofi Co.) is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinic, Shahid Beheshti research institute for endocrine sciences
Full name of responsible person
Dr. Amir Abbas Momenan
Street address
Yaman Ave., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
info@endocrine.ac.ir
Web page address
http://endocrine.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Marham daru
Full name of responsible person
Mohammad jafar Rahmani
Street address
Payvand Bldg,NO. 46 A, Nezami Ganjavi St., Vali e Asr Ave, Tehran - Iran
City
tehran
Province
Tehran
Postal code
1434814893
Phone
+98 21 8888 3837
Fax
+98 21 8867 6876
Email
Info@marhamdaru.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Marham daru
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
Tavan Institute
Full name of responsible person
Ali Aghaei
Position
Project manager
Latest degree
Master
Other areas of specialty/work
pharmacy
Street address
Unit 34, No. 69, Habibzadegan Ave., Teymuri St.,Tehran, Iran
City
tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Fax
+98 21 6600 7026
Email
info@tavaninstitute.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Seyed Mohsen Foroutan
Position
Principal investigator
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 34, No. 69, Habibzadegan Ave., Teymuri St.,Tehran, Iran
City
tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Fax
+98 21 6600 7026
Email
info@tavaninstitute.ir
Person responsible for updating data
Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Ali Aghaei
Position
project manager
Latest degree
Master
Other areas of specialty/work
pharmacy
Street address
Unit 34, No. 69, Habibzadegan Ave., Teymuri St.,Tehran, Iran
City
tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Fax
+98 21 6600 7026
Email
info@tavaninstitute.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