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CTRI Number  CTRI/2025/09/094225 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   To compare PK/PD study of Insulin Degludec and Insulin Aspart Injection 100 Units/ml insulin degludec and insulin aspart injection 100 units/mL of G. C Chemie Pharmie Limited, India comparing with Ryzodeg (Insulin degludec/Insulin aspart) 100 units/mL of Novo Nordisk in Healthy male subjects. 
Scientific Title of Study   A double blind, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover, pharmacokinetic and pharmacodynamic bioequivalence study of insulin degludec and insulin aspart injection 100 units/mL of G. C Chemie Pharmie Limited, India comparing with Ryzodeg (Insulin degludec/Insulin aspart) 100 units/mL of Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark, in healthy, adult, human male subjects using Euglycemic clamp technique under fasting conditions.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AR136 - 24 Version No & Date 01 & 24 Oct 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSowmya Bondalapati 
Designation  Principal Investigator 
Affiliation  ADVITY Research Pvt. Ltd. 
Address  ADVITY Research Pvt. Ltd 3rd and 4th Floors Archies Continental Plot No 2A 3 S.No. 1094 and 1095 Adj Kukatpally Metro station Kukatpally Hyderabad 500072 Telangana India

Hyderabad
TELANGANA
500072
India 
Phone  4069089999  
Fax    
Email  sowmya.bondalapati@advityresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Vasudev Sureddy 
Designation  Executive Director and COO 
Affiliation  ADVITY Research Pvt. Ltd. 
Address  ADVITY Research Pvt. Ltd 3rd and 4th Floors Archies Continental Plot No 2A 3 S.No. 1094 and 1095 Adj Kukatpally Metro station Kukatpally Hyderabad 500072 Telangana India

Hyderabad
TELANGANA
500072
India 
Phone  4069089999  
Fax    
Email  vasudev.sureddy@advityresearch.com  
 
Details of Contact Person
Public Query  
Name  Venkatasubbaiah Narra 
Designation  GM - RA & CPD 
Affiliation  G.C. Chemie Pharmie Limited 
Address  G.C Chemie Pharmie Limited 5C Shree Laxmi Industrial Estate New Link Road Andheri West Mumbai Mumbai MAHARASHTRA 400053 India

Mumbai
MAHARASHTRA
400053
India 
Phone  8657443730  
Fax    
Email  regulatory@gccpl.com  
 
Source of Monetary or Material Support  
G. C. Chemie Pharmie Ltd 
 
Primary Sponsor  
Name  G. C. Chemie Pharmie Ltd 
Address  5/C, Shree Laxmi Indl. Estte, New Link Road, Andheri (West), Mumbai – 400053, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSowmya Bondalapati  ADVITY Research Pvt. Ltd.  ADVITY Research Pvt. Ltd 3rd and 4th Floors Archies Continental Plot No 2A 3 S.No. 1094 and 1095 Adj Kukatpally Metro station Kukatpally Hyderabad 500072 Telangana India
Hyderabad
TELANGANA 		 4069089999

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  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insulin degludec and insulin aspart injection 100 units/mL  Dose: 0.5 IU/kg Frequency: Single dose Route of administration: subcutaneous Duration of the study: Total expected duration of the study will be at least 21 days (including the 11.00 hours prior dosing in period 1 till discharge in period 2). The Washout period will be at least 14 days.  
Comparator Agent  Ryzodeg (Insulin degludec/Insulin aspart) 100 units/mL   Dose: 0.5 IU/kg Frequency: Single dose Route of administration: subcutaneous Duration of the study: Total expected duration of the study will be at least 21 days (including the 11.00 hours prior dosing in period 1 till discharge in period 2). The Washout period will be at least 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Subjects who are able to communicate effectively.
2. Normal range for OGTT.
3. Truly voluntary participation.
4. Subjects willing to adhere to the protocol requirements and capable to provide written informed consent and able to comprehend and be informed of the nature of the study.
5 Body mass index in the range of 18.5 to 24.9 weight should be greater than equals to 50 Kg.
6. HbA1c less than 5.7 percent.
7. Normal 12 lead ECG.
8. Normal chest X ray.
9. Normal laboratory parameters
10.Absence of disease markers of HIV 1 and 2 hepatitis B and C virus and VDRL
11.Subject willing to abstain from all kinds of alcoholic beverages smoking or chewing tobacco pan or pan masala gutkha masala containing betel nut and tobacco, having caffeine or xanthine containing foods or beverages like chocolate tea coffee or cola drinks from 72.00 hours prior to period 01 admission until the last 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   Pharmacy-controlled Randomization 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary PK Parameter:
INS-AUC0-t, INS-AUC0-inf, and Cmax

Primary PD Parameter:
GIR-AUC0-24 and GIRmax 		 0-120 Hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary PK Parameter:
Tmax , t1/2 & Kel

Secondary PD Parameter:
TGIRmax
 		 0-120 Hrs 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A double blind, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover, pharmacokinetic and pharmacodynamic bioequivalence study of insulin degludec and insulin aspart injection 100 units/mL of G. C Chemie Pharmie Limited, India comparing with Ryzodeg (Insulin degludec/Insulin aspart) 100 units/mL of Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark, in healthy, adult, human male subjects using Euglycemic clamp technique under fasting conditions. 
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