| CTRI Number |
CTRI/2022/11/047188 [Registered on: 10/11/2022] Trial Registered Prospectively |
| Last Modified On: |
21/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Phase I Clinical Study to evaluate PK & PD of GeneSys Insulin Aspart |
|
Scientific Title of Study
|
A double blind, balanced, randomized, two-treatment, two-sequence, two-period, single dose, cross over, pharmacokinetic and pharmacodynamic bioequivalence study of GEN1503PR (Insulin Aspart (r-DNA origin) Injection) 100 U/mL of GeneSys Biologics Pvt. Ltd. Hyderabad, India and NovoRapid® (Insulin Aspart (r-DNA origin) Injection) 100 U/mL of Novo Nordisk, in healthy adult, male human subjects using Euglycemic clamp technique under fasting conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AR003-21 Ver. No. 01, Dt: 23 May 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowmya Bondalapati |
| Designation |
Principal Investigator |
| Affiliation |
ADVITY Research Pvt. Ltd., |
| Address |
3rd & 4th Floors,
Archies Continental,
Adj: Kukatpally Metro station,
Kukatpally
Hyderabad
TELANGANA
500072
India |
| Phone |
9848582761 |
| Fax |
|
| Email |
sowmya.bondalapati@advityresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Tulasi Ramu Chatadi |
| Designation |
Director, Head-QC, Analytics, Clinical & Regulatory |
| Affiliation |
GeneSys Biologics Pvt. Ltd., |
| Address |
Plot No. 9A, Genome Valley, Biotech Park, Phase II(Extn.,), Lalgadi Malakpet, Shamirpet
Medchal
TELANGANA
500101
India |
| Phone |
7032777482 |
| Fax |
|
| Email |
tulasi@genesysbiologics.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Venkat Reddy Yelma |
| Designation |
Managing Director |
| Affiliation |
GeneSys Biologics Pvt. Ltd., |
| Address |
Plot No. 9A, Genome Valley, Biotech Park, Phase II(Extn.,), Lalgadi Malakpet, Shamirpet
Medchal
TELANGANA
500101
India |
| Phone |
7032777481 |
| Fax |
|
| Email |
venkat.reddy@genesysbiologics.com |
|
|
Source of Monetary or Material Support
|
| GeneSys Biologics Pvt. Ltd.,
Plot No. 9A, Genome Valley, Biotech Park, Phase II(Extn.,), Lalgadi Malakpet, Shamirpet, Medchal-Malkajgiri-500101, Telangana, India
|
|
|
Primary Sponsor
|
| Name |
GeneSys Biologics Pvt. Ltd. |
| Address |
Plot No. 9A, Genome Valley, Biotech Park, Phase II (Extn.,), Lalgadi Malakpet, Shamirpet, Medchal-Malkajgiri-500101, Telangana, 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 Sowmya Bondalapati |
ADVITY Research Pvt. Ltd., |
3rd & 4th Floors,
Archies Continental,
Adj: Kukatpally Metro station,
Kukatpally
Hyderabad
TELANGANA |
9848582761
sowmya.bondalapati@advityresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vasavi Medical & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GEN1503PR |
Dose: 0.3 IU/kg
Frequency: Single Dose
Route of Administration: Subcutaneous
Duration of the study: Total expected duration of the study will be of at least 07 days (including
the 11.00 hours prior to dosing in period 01 till discharge in period 02). The
washout period will be at least 05 days. |
| Comparator Agent |
NovoRapid |
Dose: 0.3 IU/kg
Frequency: Single Dose
Route of Administration: Subcutaneous
Duration of the study: Total expected duration of the study will be of at least 07 days (including
the 11.00 hours prior to dosing in period 01 till discharge in period 02). The
washout period will be at least 05 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Healthy human subjects between 18-45 years of age.
2. Subjects able to communicate effectively.
3. Normal range for OGTT.
4. Truly voluntarily participation.
5. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
6. Body mass index in the range of 18.5 to 24.9 kg/m2 (weight should be ≥ 50 Kg).
7. Normal 12-lead ECG
8. Normal chest X-ray
9. Normal laboratory parameters
10. Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL
11. Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 72.00 hours before admission till the last post-dose blood sample collection in each study period. |
|
| ExclusionCriteria |
| Details |
1. Subjects having history of contraindication or hypersensitivity (e.g., anaphylaxis) to Insulin
or related class of drugs will be excluded from the study.
2. A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
3. History or presence of diabetes, migraine, hypertension, cardiovascular, pulmonary, endocrine, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
4. History or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.
5. History or presence of significant systemic diseases, seizures, psychiatric disorders, neurological disorders.
6. History of diabetic ketoacidosis
7. History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting)
8. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
9. Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
10. Participation in a drug research study within 90 days prior to dosing of this study.
11. Blood loss or whole blood donation within 90 days prior to drug administration.
12. Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day).
13. History of addiction to any recreational drug or drug dependence.
14. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons.
15. History of dehydration from diarrhea, vomiting or any other reason within a period of 48.00 hours prior to study admission of each period.
16. Positive results for drugs of abuse (benzodiazepines, cocaines, opioids, amphetamines,
cannabinoids and barbiturates) in urine during the admission of each study period.
17. Positive results for alcohol consumption during the admission of each study period.
18. History of pre-existing bleeding disorder.
19. Difficulty with donating blood.
20. Difficulty in swallowing oral solids like tablets / capsules.
21. Blood pressure on the day of admission of each study period
a. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
b. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
22. Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission of each study period.
23. History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary PK Parameters:
INS-AUC0-t, INS-AUC0-inf, Cmax
Primary PD Parameters:
GIR-AUC0-12 and GIRmax |
0-12 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary PK Parameters:
Tmax , t1/2 and Kel
Secondary PD Parameters:
TGIRmax |
0-12 hrs |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/11/2022 |
| Date of Study Completion (India) |
07/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to assess and compare the pharmacokinetic and pharmacodynamic properties of GEN1503PR with NovoRapid® |