Study of the pharmacokinetic and pharmacodynamic and safety properties of Somatin® (5 mg/1.5 ml cartridges, AryaTinaGene Biopharmaceutical Co) in comparison to Norditropin® (5 mg/1.5 ml cartridges, Novo Nordisk) in healthy volunteers
This study is designed to compare the pharmacokinetic and pharmacodynamic of Somatin® and Norditropin® in healthy volunteers.
Design
This randomized, single-dose, two-way, crossover study is conducted to compare the pharmacodynamic and pharmacokinetic of Somatin® and Norditropin® in 30 healthy adults volunteers. Volunteers will be sorted and receive a number from 1 to 30. In the first phase of the study, 15 volunteers will receive Somatin® produced by AryaTinaGene Biopharmaceutical Co. and the remaining 15 volunteers will receive Norditropin® produced by Novo Nordisk Co.The administered drugs will be replaced by each other in the second phase of the study.
Settings and conduct
The dose administration and subsequent sample collection will be performed in S. Motahhari hospital (Gonbade Kavous, Iran).
Participants/Inclusion and exclusion criteria
Volunteers,18-50 years of age. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. Good health at screening. Exclusion criteria: History of any drug hypersensitivity or intolerance. Significant history or current evidence of chronic disease. Receipt of any drug as part of a research study within 30 days prior to the present study.
Intervention groups
First intervention group: a single subcutaneous injection of Somatin (5 mg) manufactured by AryaTinaGene Biopharmaceutical Co. to 15 subjects. Second intervention group: A single subcutaneous injection of Norditropin (5 mg) manufactured by Novo Nordisk Co. to 15 subjects. Since in this study, the volunteers will receive both Test and Reference drugs, each volunteer will act as his own control.
Main outcome variables
Drug serum concentration; area under the serum concentration-time curve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130626013776N20
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
Update count:1
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Hossein Amini
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1651
Email address
hamini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the pharmacokinetic and pharmacodynamic and safety properties of Somatin® (5 mg/1.5 ml cartridges, AryaTinaGene Biopharmaceutical Co) in comparison to Norditropin® (5 mg/1.5 ml cartridges, Novo Nordisk) in healthy volunteers
Public title
Bioequivalence Study of Somatropin in Healthy Human Volunteers
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteers, 18-50 years of age.
The subject is able and willing to provide signed informed consent.
The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent.
The subject has stable residence and telephone.
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Exclusion criteria:
History of allergy or sensitivity to somatropin.
History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study.
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
Presence of gastrointestinal disease or history of malabsorption within the last year.
History of a medical disorders occurring within the last year that required hospitalization or medication.
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
Receipt of any drug as part of a research study within 30 days prior to the present study.
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.
Age
From 18 years old to 50 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
16
A volume of 2 ml of blood is obtained in each sampling time through a venous cannula
Randomization (investigator's opinion)
Randomized
Randomization description
Each subject is identified by a number from 1 to 30. This number is allocated according to their entrance to volunteers' list in the screening day. Then, the following randomization table is used according to the crossover design of the study. All participants randomized into two sequences of Test/Reference and Reference/Test products
Subjects Dosing Sequence Day 1 Day 8
1 R/T Reference Test
2 T/R Test Reference
3 T/R Test Reference
4 R/T Reference Test
5 T/R Test Reference
6 R/T Reference Test
7 R/T Reference Test
8 T/R Test Reference
9 T/R Test Reference
10 T/R Test Reference
11 R/T Reference Test
12 R/T Reference Test
13 T/R Test Reference
14 T/R Test Reference
15 T/R Test Reference
16 R/T Reference Test
17 T/R Test Reference
18 R/T Reference Test
19 R/T Reference Test
20 R/T Reference Test
21 T/R Test Reference
22 T/R Test Reference
23 R/T Reference Test
24 R/T Reference Test
25 R/T Reference Test
26 R/T Reference Test
27 T/R Test Reference
28 T/R Test Reference
29 T/T Test Reference
30 R/T Reference Test
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 Golestan University of Medical Sciences
Street address
Falsafi Building, Sari Road Km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-03-09, 1398/12/19
Ethics committee reference number
IR.GOUMS.REC.1398.352
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum concentration of somatropin, IGF-1 and IGFBP-3
Timepoint
−1.0, −0.5, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours after injection
Method of measurement
Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay
2
Description
Area under serum concentration-time curve
Timepoint
−1.0, −0.5, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 96 hours after injection
Method of measurement
Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay
Secondary outcomes
1
Description
Time to reach maximum serum concentration
Timepoint
Sampling at times of 1, 2, 3, 4 and 6 hours after injection
Method of measurement
From serum concentration-time curve
2
Description
Serum half-life
Timepoint
From the terminal 84 hours of serum concentration-time profile
Method of measurement
Blood sampling and measurement of serum concentrations by chemiluminescence immunoassay
Intervention groups
1
Description
Intervention group: A subcutaneous injection of a single dose of 5 mg of Somatin produced by AryaTinaGene Biopharmaceutical Co. to healthy volunteers
Category
Treatment - Drugs
2
Description
Intervention group: A subcutaneous injection of a single dose of 5 mg of Norditropin produced by Novo Nordisk Co. to healthy volunteers.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Center, S. Motahhari Hospital
Full name of responsible person
Yahya Naserifard
Street address
Taleghani Street
City
Gorgan
Province
Golestan
Postal code
4916817693
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AryaTinaGene Biopharmaceutical Co
Full name of responsible person
Dr. Majid Shahbazi
Street address
Aqqala Industrial Estate
City
Gorgan
Province
Golestan
Postal code
4931171756
Phone
+98 17 3453 3545
Fax
+98 17 3453 3554
Email
info@atgbio.com
Web page address
http://atgbio.com/home
Grant name
AryaTinaGene Biopharmaceutical Co
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AryaTinaGene Biopharmaceutical Co
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
Gorgan University of Medical Sciences
Full name of responsible person
Hossein Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sari Road, Km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hossein Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sari Road, Km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hossein Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sari Road, Km 2
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3252 5972
Fax
+98 17 3252 5972
Email
haminhplc@yahoo.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
Data are confidential and need permission from the company.