| CTRI Number |
CTRI/2023/02/050076 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bio-equivalence study of Biphasic Insulin Aspart Injection (30/70) |
|
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 (30/70) and
Novomix® 30, in Healthy Subjects |
| Trial Acronym |
W-ASP (B)-103 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| W-ASP (B)-103, Version Number 01, dated 22 Jan 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilesh Lomte |
| Designation |
Consultant |
| Affiliation |
Wockhardt Limited |
| Address |
Clinical Pharmacokinetics and Biopharmaceutics Department Wockhardt Limited D-4 MIDC Area
Aurangabad
Aurangabad
MAHARASHTRA
431 006
India |
| Phone |
02406651600 |
| Fax |
|
| Email |
enileshlomte@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Manishkumar D Shah |
| Designation |
Vice President - Global Clinical Development |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt Towers, A wing, Global Clinical Development Bandra Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226590000 |
| Fax |
|
| Email |
Manish.Shah@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Shraddha Tawade |
| Designation |
Associate Vice President |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt Limited Bandra Kurla Complex Bandra East Mumbai
Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226590000 |
| Fax |
|
| Email |
STawade@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt BIO AG Grafenauweg 6 6300 Zug Switzerland |
|
|
Primary Sponsor
|
| Name |
Wockhardt Bio AG |
| Address |
Grafenauweg 6 6300 Zug Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Wockhardt LimitedResearch Centre |
MIDC, D-4, MIDC, Chikalthana AurangabadMaharashtra (India) - 431006 |
|
|
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 |
Research and Development Centre - Wockhardt Limited |
Clinical Pharmacokinetics and Biopharmaceutics Department, Clinical Pharmacology Unit, D-4,MIDC Area,
Aurangabad-431006
Aurangabad
MAHARASHTRA |
02406651600
enileshlomte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Government Medical College, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To test comparative efficacy of drugs used in diabetes mellitus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NovoMix® 30 (100 IU/ml)cartridges/pens 3.0 ml |
Dose-0.3 IU/kg subject body weight ,
Frequency - Single Dose (Once) ,
Route of administration-Subcutaneous (SC),
Total Duration -24 hours Clamp |
| Intervention |
Wockhardt’s Biphasic Insulin Aspart Injection (30/70) 100 IU/ml cartridges 3.0 ml |
Dose-0.3 IU/kg subject body weight , Frequency - Single Dose (Once) , Route of administration-Subcutaneous (SC), Total Duration -24 hours Clamp |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Subjects weight within the normal range according to normal values for the Body Mass Index (18.5 to 27.0 -kg/m2, inclusive) with minimum of 50 kg weight.
Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
Subjects having clinically acceptable chest X-Ray (PA view).
Non-smoker, defined as no nicotine/tobacco consumption for last six months. |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to Insulin or related class of drugs.
History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
Subjects with hemoglobin levels <12.5 gm/dl at screening or hemoglobinopathy.
Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
History or presence of alcoholism or drug abuse
HbA1c values (at screening) ≥ 5.7%. |
|
|
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 (Cmax and AUC0-24h) of two Recombinant Human
Insulin Analogues - Wockhardt’s Biphasic Insulin Aspart Injection (30/70) and NovoMix® 30 in healthy adult male subjects. |
0-24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To test for bioequivalence based on the pharmacodynamic
parameters (AUCGIR,0-24h, and GIRmax) of two Recombinant
Human Insulin Analogues - Wockhardt’s Biphasic Insulin Aspart Injection (30/70) and NovoMix® 30 in healthy adult male subjects |
0-24 hrs |
To compare the pharmacokinetic and pharmacodynamic profile as
well as assess safety and local tolerability of the two Recombinant Human Insulin Analogues. |
Entire duration of study |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
27/02/2023 |
| Date of Study Completion (India) |
14/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |