| CTRI Number |
CTRI/2016/02/006645 [Registered on: 16/02/2016] 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
|
BA BE trial of Wosulin(Insulin) Regular (E.Coli) |
|
Scientific Title of Study
|
A Randomized, Single Centre, Double Blind Three Treatment Three Period, Crossover Glucose Clamp Study to Test for Bioequivalence between Recombinant Human Insulins, Wockhardt’sWosulin Regular Insuln Human (E. Coli) with Wockhardt’s Wosulin Regular Insulin Human (Yeast) and Bioequivalence between Wockhardt’s Wosulin Regular Insulin Human (E.Coli) with Humulin® R, in Healthy Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| W-WOS-102 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hiren Prajapati |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical Research Pvt. Ltd. |
| Address |
Shivalik Plaza, Near I.I.M., Ambawadi
Ahmadabad
GUJARAT
380 015
India |
| Phone |
9179-30013000 |
| Fax |
|
| Email |
Hiren.Prajapati@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shraddha Tawade |
| Designation |
GM |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt Towers Bandra Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
91-22-26596831 |
| Fax |
|
| Email |
stawade@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Preeti Narayan |
| Designation |
Sr. Manager |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt Towers Bandra Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
91-22-26596857 |
| Fax |
|
| Email |
pnarayan@wockhardt.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Towers, bandra Kurla Complex |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Hiren Prajapati |
Veeda Clinical Research Pvt. Ltd. |
Shivalik Plaza, Near I.I.M., Ambawadi
Ahmadabad
GUJARAT |
7930013000
7930013010
Hiren.Prajapati@veedacr.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anveshhan Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Insulin Humulin® R |
Insulin Humulin® R (600 nmol/ml, 100 IU/ml), vials 10.0 ml |
| Comparator Agent |
Wockhardts Wosulin R (Yeast) |
Wosulin R (Yeast, 600 nmol/ml, 100 IU/ml), vials 10.0 ml |
| Intervention |
Wockhardts Wosulin R (E.Coli) |
Wosulin R (E.Coli, 600 nmol/ml, 100 IU/ml), vials 10.0 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Male subjects aged between 18 and 45 years both inclusive
Subjects weight within the normal range according to normal values for the Body Mass Index -18.50 to 27.00 kg/m2, inclusive with minimum of 50 kg weight
Subjects without any evidence of impaired glucose tolerance in 2 hour OGTT.
Subjects having clinically acceptable 12-lead electrocardiogram (ECG). |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to Insulin or related class of drugs.
Subjects with hemoglobin levels 12.15 gm/dl at screening or hemoglobinopathy will not be eligible for the study
Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows:
• Wockhardt’s Regular Insulin Human (Yeast) and Wockhardt’s Regular Insulin Human (E.Coli)
• Wockhardt’s Regular Insulin Human (E.Coli) and HUMULIN® R
|
The primary objective is to test for bioequivalence based on the pharmacokinetic parameters (Cmax and AUC0-12h) and pharmacodynamic parameters (AUCGIR0-12h, and GIRmax) between recombinant human insulin formulations in healthy subjects as follows:
• Wockhardt’s Regular Insulin Human (Yeast) and Wockhardt’s Regular Insulin Human (E.Coli)
• Wockhardt’s Regular Insulin Human (E.Coli) and HUMULIN® R
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives are to compare the pharmacokinetic and pharmacodynamic profile as well as assessing safety and local tolerability of the three insulin preparations. |
during the 3 clamp |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
26/02/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
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)?
|
|
Brief Summary
|
The study is still in start up phase |