| CTRI Number |
CTRI/2021/04/032482 [Registered on: 01/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Pharmacodynamics end point study on Tetracosactide Injection |
|
Scientific Title of Study
|
Single dose two-way crossover bioequivalence pharmacodynamics end point study on Tetracosactide Injection BP 250 mcg/mL in healthy adult human subjects under fasting condition |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TET55 Version 1.0 Amendment 2.0 dated 21 Dec 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirti Patel |
| Designation |
Senior Research Manager |
| Affiliation |
Sun Pharmaceutical Industries Ltd |
| Address |
Clinical Pharmacology Unit, 2nd Floor HAH-Centenary Hospital
Hamdard Nagar
South
DELHI
110062
India |
| Phone |
09898555723 |
| Fax |
|
| Email |
Kirti.Patel@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Mehra |
| Designation |
General Manager |
| Affiliation |
Sun Pharmaceutical Industries Ltd |
| Address |
Clinical Pharmacology Unit, 2nd Floor HAH-Centenary Hospital
Hamdard Nagar
South
DELHI
110062
India |
| Phone |
09810771534 |
| Fax |
|
| Email |
Sachin.mehra@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arshad H Khuroo |
| Designation |
Associate Vice President |
| Affiliation |
Sun Pharmaceutical Industries Ltd |
| Address |
Clinical Pharmacology and Pharmacokinetics Sun Pharmaceutical Industries Limited Plot No GP5 Sector 18 Udyog Vihar Industrial Area HSIDC Old Delhi Gurugram Road
Gurgaon
HARYANA
122 015
India |
| Phone |
09810613226 |
| Fax |
|
| Email |
ARSHAD.KHUROO@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Medicare Limited Survey No 22 & 24, Village: Ujeti, Post: Baska, Taluka: Halol 389350, District: Panchmahal, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Medicare Limited |
| Address |
Survey No 22 & 24, Village: Ujeti, Post: Baska, Taluka: Halol 389350,
District: Panchmahal, Gujarat, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kirti Patel |
Clinical Pharmacology Unit- New Delhi |
Clinical Pharmacology Unit
Sun Pharmaceutical Industries Limited
Hakeem Abdul Hameed Centenary Hospital (2nd Floor)
Jamia Hamdard (Hamdard University)
Hamdard Nagar
South
DELHI |
09898555723
Kirti.Patel@sunpharma.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee (JHIEC) Jamia Hamdard, Hamdard Nagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
diagnostic test for the investigation of adrenocortical insufficiency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Synacthen 250 mcg/mL (Tetracosactide hexaacetate solution for Injection) of Alfasigma S.P.A. Via Pontina km 30.400 I-00040 Pomezia (Rom) Italien |
Healthy subjects will be randomly assigned in a 1:1 ratio to receive either Sun Pharmaceutical Medicare Limited, India Tetracosactide Injection BP 250 mcg/mL or Synacthen 250 mcg/mL (Tetracosactide hexaacetate solution for Injection) in each period. Each subject will be administered a single dose (1 mL Ampoule) of either test product (T) or reference product (R) of Tetracosactide Injection 250 mcg/mL and this dose will be administered via intravenous route slowly over a period of 2 minute by study physician/ nursing staff. After 5 day wash out, Healthy subjects will cross over to the other formulation as per randomization schedule. Duration of therapy is one day considering single dose study. |
| Intervention |
Tetracosactide Injection BP 250 mcg/mL of Sun Pharmaceutical Medicare Limited, India |
Healthy subjects will be randomly assigned in a 1:1 ratio to receive either Sun Pharmaceutical Medicare Limited, India Tetracosactide Injection BP 250 mcg/mL or Synacthen 250 mcg/mL (Tetracosactide hexaacetate solution for Injection) in each period. Each subject will be administered a single dose (1 mL Ampoule) of either test product (T) or reference product (R) of Tetracosactide Injection 250 mcg/mL and this dose will be administered via intravenous route slowly over a period of 2 minute by study physician/ nursing staff. After 5 day wash out, Healthy subjects will cross over to the other formulation as per randomization schedule. Duration of therapy is one day considering single dose study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject is in the age range of 18-50 years.
2. Subject has voluntarily given written informed consent to participate in this study.
3. Subject is healthy as determined by medical history and physical examination performed within 28 days prior to the commencement of the study.
4. Subject must have clinically acceptable results for all the screening parameters and laboratory investigations.
5. Subject has body mass index (BMI) greater than or equal 18.50 and less than 30.00 kg/m2.
6. Subject has hemoglobin level greater than or equal 12.0 g/dL (Deciliter) for males or greater than or equal 11.0 g/dL for females.
7. If subject is female and:
a) Of childbearing potential, is practicing or willing to practice an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
b) Is post-menopausal (Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago) or
c) Is surgically sterile (Hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months ago)
|
|
| ExclusionCriteria |
| Details |
1. Subject has history of hypersensitivity to tetracosactide or any other similar class of drugs.
2. Subject has history of psychological disturbances (e.g. euphoria, insomnia, mood swings, personality changes and severe depression, or even frank psychotic manifestations)
3. Subject has history of tuberculosis/amoebiasis and/or has any sequelae as a result of these infections in the past.
4. Subject has history of drug induced rash and/or pruritus.
5. Subject has any evidence of organ dysfunction or any clinically significant abnormality as determined from physical or clinical examinations.
6. Subject has history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease etc., systemic diseases including but not limited to diabetes, hypertension, sarcoidosis, rheumatic diseases & thyroid abnormalities, diseases like immunosuppression, glaucoma and/ or any serious, potentially life-threatening illness.
7. Subject has inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide, written informed consent.
8. Subject is a regular smoker, who smokes more than 10 cigarettes daily or has difficulty abstaining from smoking for the duration of study period.
9. Subject has history of drug dependence or excessive alcohol intake on a habitual basis or has difficulty in abstaining or found positive in urinary alcohol test before admission.
10. Subject has used any medication (Including females taking oral contraceptives) within 30 days prior to admission of this study.
11. Subject has donated blood (1 unit or 350 mL) or received an investigational medicinal product within 90 days prior to receiving the first dose of study drug. Elimination half-life of the study drug should be taken into consideration for his/ her inclusion in the study.
a)Note: If subject had participated in a study at CPU New Delhi in which blood loss
was less than or equal to 200 mL, subject may be dosed 60 days after the last
pharmacokinetic sample of previous study.
12. Subject has consumed alcohol 48 hours prior to admission.
13. Subject has consumed grapefruit juice and or grape fruit supplements containing products 48 hours prior to admission.
14. If subject is a female volunteer and demonstrating a positive pregnancy test prior to admission.
15. If subject is a female volunteer and currently breast-feeding. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this study is to compare the plasma cortisol (pharmacodynamics marker) concentration response of Test product (T) and Reference product (R), administered as a 1 mL x 250 mcg/mL injection, in healthy, adult, human subjects under fasting conditions. |
At the end of the study when all 48 Subjects have completed the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of this study is to monitor the safety of Test product (T) and Reference product (R) in healthy, adult, human subjects under fasting condition. |
At the end of the study when all 48 Subjects have completed the study |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence, pharmacodynamics (PD) end point study under fasting condition. The primary objective of this study is to compare the plasma cortisol (pharmacodynamics marker) concentration response of Test product (T) and Reference product (R), administered as a 1 mL x 250 mcg/mL injection, in healthy, adult, human subjects under fasting conditions. |