FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/104468 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Study to Compare Biphasic Insulin Aspart Injection (30/70) with NovoMix ® 30 in healthy adult male subjects 
Scientific Title of Study   A Randomized, Single Center, Double Blind, Two-Period, Crossover Glucose Clamp Study to test for bioequivalence between two Recombinant Human Insulin Analogues - Wockhardt’s Biphasic Insulin Aspart Injection (30 by 70) and NovoMix® 30, in Healthy Subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
: W-ASP (B)-104, Version Number 02, dated 15/Apr/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nilesh Lomte 
Designation  Consultant , Clinical Pharmacokinetics and Biopharmaceutics Department 
Affiliation  Wockhardt Limited 
Address  D4 - MIDC Area, Chikalthana

Aurangabad
MAHARASHTRA
431006
India 
Phone  02406694125  
Fax    
Email  enileshlomte@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Radhika A 
Designation  AGM – Global Clinical Development, NCE 
Affiliation  Wockhardt limited  
Address  Wockhardt Limited Wockhardt Towers, Bandra-Kurla Complex (BKC), Bandra (East), Mumbai – 400051, Maharashtra, India

Mumbai
MAHARASHTRA
400051
India 
Phone  8728830894  
Fax    
Email  RadhikaA@wockhardt.com  
 
Details of Contact Person
Public Query  
Name  Ranjeet Gutte 
Designation  VP-Global Clinical Development  
Affiliation  Wockhardt limited  
Address  Wockhardt Limited Wockhardt Towers, Bandra-Kurla Complex (BKC), Bandra (East), Mumbai – 400051, Maharashtra, India

Mumbai
MAHARASHTRA
400051
India 
Phone  02271596306  
Fax    
Email  rgutte@wockhardt.com  
 
Source of Monetary or Material Support  
Wockhardt BIO AG Grafenauweg 6 6300 Zug Switzerland  
 
Primary Sponsor  
Name  Wockhardt limited 
Address  Wockhardt Limited Wockhardt Towers, Bandra-Kurla Complex (BKC), Bandra (East), Mumbai – 400051, Maharashtra, 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 
Dr Nilesh Lomte  Wockhardt Limited  Clinical Pharmacokinetics and Biopharmaceutics Department Wockhardt Limited, D4 - MIDC Area, Chikalthana, Aurangabad-431 006 (India) Tel: +91 0240 - 6651600
Mumbai
MAHARASHTRA 		 02406651600

enileshlomte@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects  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  Wockhardt’s Biphasic Insulin Aspart Injection (30 by 70)  Each subject will be randomized to receive single subcutaneous injection of either of the trial drugs on two separate dosing visits, one injection with Biphasic Insulin Aspart Injection (30/70) soluble. 
Comparator Agent  NovoMix® 30  Each subject will be randomized to receive single subcutaneous injection of either of the trial drugs on two separate dosing visits, one injection with NovoMix®30. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Male subjects aged between 18 and 45 years (both inclusive).
2. Subjects weight within the normal range according to normal values for the Body Mass Index (18.5 to 27.0 kg per hr, inclusive) with minimum of 50 kg weight.
3. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
5. Subjects having clinically acceptable chest X-Ray (PA view).
6. Non-smoker, defined as no nicotine or tobacco consumption for last six months.
7. Have a negative urine screen for drugs of abuse.
8. Have a negative alcohol test.
9. Subjects willing to adhere to the protocol requirements.
10. Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.
11. Subject agrees to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from screening till 90 days following the last administration of the study drug and to not donate sperm during this period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
 
 
ExclusionCriteria 
Details  1. Hypersensitivity to Insulin or related class of drugs.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Subjects with hemoglobin levels less than 12.5 gm per dl at screening or hemoglobinopathy.
4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
5. History or presence of alcoholism or drug abuse in the past one year.
6. HbAlc values (at screening) greater than or equal to 5.7%.
7. Subjects who are Hepatitis B or C or HIV or VDRL positive.
8. History or presence of significant asthma, urticaria or other allergic reactions.
9. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
10. History or presence of cancer.
11. Family history of diabetes mellitus.
12. Difficulty in donating blood.
13. Major illness in the past.
14. Subjects who donated 350 ml or more blood within 90 days.
15. Subjects who have received any investigational drug within 90 days from screening visit.
16. Use of prescription and non-prescription drugs, except routine vitamins, within 2 weeks prior to screening/randomization. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To test for bioequivalence based on the pharmacokinetic parameters ( C max and AUC O-12h ) of two Recombinant Human Insulin Analogues - Wockhardts Biphasic Insulin Aspart Injection (30 by 70) and NovoMix 30 in healthy adult male subjects.  0-12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To test for bioequivalence based on the pharmacodynamic parameters (AUCGIR, 0 -
12h, & GIRmax) of two Recombinant Human Insulin Analogues- Wockhardts
Biphasic Insulin Aspart Injection (30 by 70) & NovoMix 30 in healthy adult male subjects. 		 0-12 hours 
To compare the pharmacokinetic & pharmacodynamic profile as well as assess
safety & local tolerability of the two Recombinant Human Insulin Analogues. 		 0-12 hours 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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)   01/04/2026 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available upon request

  6. For how long will this data be available start date provided 01-04-2026 and end date provided 01-04-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study objective is to test for bioequivalence based on pharmacokinetic and pharmacodynamic parameters of two Recombinant Human Insulin Analogues -Wockhardt’s Biphasic Insulin Aspart Injection (30/70) and NovoMix® 30 in healthy subjects.

 
Close