| CTRI Number |
CTRI/2016/07/007117 [Registered on: 25/07/2016] Trial Registered Prospectively |
| Last Modified On: |
28/09/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
PK-PD trial BETWEEN TWO INSULINS; WOSULIN R (200 IU) WITH WOSULIN R (100 IU) IN HEALTHY SUBJECTS |
|
Scientific Title of Study
|
A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO-PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST BIOEQUIVALENCE BETWEEN TWO FORMULATIONS OF RECOMBINANT HUMAN INSULINS; WOSULIN R (200 IU) WITH WOSULIN R (100 IU) IN HEALTHY SUBJECTS. |
| Trial Acronym |
W-WOS(R)-103 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| W-WOS(R)-103 2-Dec-2015 ver 02 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Patel |
| Designation |
General manager, BiotechClampCenter |
| Affiliation |
NBCU, Wockhardt Ltd |
| Address |
NBCU, Wockhardt Ltd,
Wockhardt Hospital Campus
Wani House, Near Wadala Naka,
Mumbai-Agra Road.
Nashik
MAHARASHTRA
422001
India |
| Phone |
0253-6640600 |
| Fax |
|
| Email |
RakeshP@wockhardt.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shridhar Yeshamaina |
| Designation |
GM, Global Clinical Development |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Towers, Bandra Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-26596832 |
| Fax |
|
| Email |
SridharY@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mushtaque Mastim |
| Designation |
AGM-Global Clinical Development |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Towers, Bandra Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
022-26596841 |
| Fax |
|
| Email |
mmastim@wockhardt.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Mumbai 400051, India |
| 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 Rakesh Patel |
Nasik Bio-tec Clamp Unit, Wockhardt Ltd |
Wockhardt Hospital Campus
Wani House, Near Wadala Naka,
Mumbai-Agra Road, Nashik-422001,
Nashik
MAHARASHTRA |
0253-6640600
RakeshP@wockhardt.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nashik Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Wosulin R (100 IU) |
Wosulin R (100 IU), 10.0 ml vials or 3ml cartridge with reusable pen |
| Intervention |
Wosulin R (200 IU) |
Wosulin R (200 IU), 10.0 ml vials or 3ml cartridge with reusable pen.
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, (both
inclusive)
2.Subjects with normal results of 2 hours Oral Glucose Tolerance
Test (OGTT) performed at screening.
3. Considered generally healthy upon completion of medical
history, physical examination, X-ray chest (PA view), ECG, and
biochemical investigations. |
|
| ExclusionCriteria |
| Details |
1. HbA1c values (at screening) more than 5.7%. |
|
|
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 |
PK: AUC0-12 and Cmax
PD: AUC (GIR, 0-12h), and GIRmax |
PK: 12 hours
PD: 12 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PK endpoints: AUC0-4h, AUC0-6h, AUC6-12h, AUC0- , tmax, t½ and elimination rate
constant (ï¬z)
PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR6-12h, and tGIRmax |
Variable |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
25/07/2016 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study yet to be initiated |