| CTRI Number |
CTRI/2020/04/024787 [Registered on: 22/04/2020] Trial Registered Prospectively |
| Last Modified On: |
22/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
study to understand bio availability
wockhardt’s wosulin® 30/70 and actraphane 30 , in healthy
subjects
|
|
Scientific Title of Study
|
A randomized, single center, double blind, two treatment,
Two-period, crossover glucose clamp study to test for
Bioequivalence between biphasic isophane insulin injections
Wockhardt’s wosulin® 30/70 and actraphane 30 , in healthy
Subjects
|
| Trial Acronym |
W-WOS(M)-106 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| W-WOS(M)-106; Version Number: 03 Date: 07/Feb/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilesh Lomte |
| Designation |
Principal Investigator |
| Affiliation |
Clinical Pharmacokinetics & Biopharmaceutics Department Wockhardt Limited |
| Address |
Clinical Pharmacokinetics & Biopharmaceutics Department
Wockhardt Limited, D-4,
MIDC Area, Chikalthana,
Aurangabad-, Maharashtra, India
Aurangabad
MAHARASHTRA
431 006
India |
| Phone |
2406651600 |
| Fax |
|
| Email |
enileshlomte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mushtaque Mastim |
| Designation |
Medical Monitor |
| Affiliation |
wockhardt ltd |
| Address |
Wockhardt Towers
Bandra Kurla Complex
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
02226534444 |
| Fax |
|
| Email |
MMastim@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mushtaque Mastim |
| Designation |
Medical Monitor |
| Affiliation |
Wockhardt ltd |
| Address |
Wockhardt Towers
Bandra Kurla Complex
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
02226534444 |
| Fax |
|
| Email |
MMastim@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
|
|
|
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 |
Clinical Pharmacokinetics & Biopharmaceutics Department |
Clinical Pharmacokinetics & Biopharmaceutics Department
Wockhardt Limited, D-4,
MIDC Area, Chikalthana,
Aurangabad
MAHARASHTRA |
2406651600
enileshlomte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
assessing bio-availability of test drug |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Actraphane 30 |
Actraphane 30, vials 10.0 ml/cartridges 3.0 ml.
Single IV dose |
| Intervention |
Wosulin® 30/70 |
Wosulin® 30/70, vials 10.0 ml/cartridges 3.0 ml.
Single IV dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Subjects weight within the normal range according to normal
values for the Body Mass Index 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). |
|
| 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. Any treatment which could bring about induction or inhibition
of hepatic microsomal enzyme system within 1 month of the study drug administration.
4. History or presence of significant alcoholism or drug abuse in the past one year.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective is to test for bioequivalence based on the
pharmacokinetic parameters (Cmax and AUC0-24h) of two Biphasic
Isophane Insulin Injections, Wosulin® 30/70 and Actraphane 30 in
healthy adult male subjects. |
0-24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objectives are to compare the pharmacokinetic and
pharmacodynamic profile as well as assess safety and local
tolerability of the two Biphasic Isophane Insulin Injections. |
0-24hrs |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/04/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study objective is to test for bioequivalence based on pharmacokinetic and pharmacodynamic parameters of two Biphasic Isophane Insulin Injections, Wosulin® 30/70 and Actraphane 30 in healthy subjects. |