| CTRI Number |
CTRI/2017/08/009251 [Registered on: 03/08/2017] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence and bioavailability study on Insulin |
|
Scientific Title of Study
|
A Randomized, Single Center, Double Blind, Two Treatment, Two-Period, Crossover Glucose Clamp Study To Test For Bioequivalence Between Wockhardt’s Consegna™ - 30/70 (Bi Phasic Isophane Insulin 30/70 Injection 200 IU) and Mixtard® 30/70 (100 IU), In Healthy Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| W-WOS(M)-105; Version Number: 02;04-Jan-17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilesh Patel |
| Designation |
GM-Nashik Biotech Clamp Unit |
| Affiliation |
Nashik Biotech Clamp Unit, Wockhardt Ltd |
| Address |
Wockhardt Hospital Campus
Wani House, Near Wadala Naka,
Mumbai-Agra Road, Nashik-,
Maharashtra, India.
Nashik
MAHARASHTRA
422001
India |
| Phone |
0253-6640600 |
| Fax |
0253-2500322 |
| Email |
nileshpatel@wockhardt.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mustaque Mastim |
| Designation |
ADGM- Global Clinical Development |
| Affiliation |
Wockhardt Pvt Ltd |
| Address |
Wockhardt
Wockhart Limited
Bandra – Kurla Complex
Bandra East
Mumbai
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
91-22-26596841 |
| Fax |
|
| Email |
mmastim@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Shraddha Tawade |
| Designation |
Sr. GM- Global Clinical Development |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt
Wockhart Limited
Bandra – Kurla Complex
Bandra East
Mumbai
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
91-22-26596831 |
| Fax |
|
| Email |
STawade@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Pvt Ltd
Wockhart Towers
Bandra – Kurla Complex
Bandra East
Mumbai 400 051
|
|
|
Primary Sponsor
|
| Name |
Wockhardt Pvt Ltd |
| Address |
Wockhardt Limited
Wockhardt Towers, Bandra Kurla Complex
Mumbai – 400 051, India.
|
| 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 Nilesh Patel |
Nashik Biotech Clamp Unit, Wockhardt Ltd |
Wockhardt Hospital Campus
Wani House, Near Wadala Naka,
Mumbai-Agra Road, Nashik-422001,
India.
Nashik
MAHARASHTRA |
0253-6640600
nileshpatel@wockhardt.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nashik Independent Ethicis 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 |
MIXTARD® 30/70 |
MIXTARD® 30/70
(100 IU)
Each subject will randomly receive a single dose of each trial drug dose (20 IU) by subcutaneous injection over each periods of the study. |
| Intervention |
WOCKHARDT’S CONSEGNA™ - 30/70 |
BIPHASIC ISOPHANE INSULIN 30/70 INJECTION 200 IU
Each subject will randomly receive a single dose of each trial drug dose (20 IU) by subcutaneous injection over each periods of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
2. Subjects having clinically acceptable 12-lead
electrocardiogram (ECG).
3. Subjects having clinically acceptable chest X-Ray (PA view).
4. Non-smoker, defined as no nicotine consumption for last six months.
5.Have a negative urine screen for drugs of abuse (including amphetamine, barbiturate, benzodiazepines, marijuana (THC), cocaine, and morphine (opiate)).
6. Have a negative alcohol breath analysis.
7. Subjects willing to adhere to the protocol requirements and are agreed for verbal and written consent to audio-visual recording of the discussion of consent process and agreed to
provide the signed and dated informed consent before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal
management of the subject.)
8. Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.
9. Subject agree 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 not to donate sperm during this period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary. |
|
| ExclusionCriteria |
| Details |
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 12.00 gm/dl at screening
or hemoglobinopathy will not be eligible for the study
4. Any treatment which could bring about induction or
inhibition of hepatic microsomal enzyme system within 1
month of the study drug administration
5. History or presence of significant alcoholism or drug abuse in
the past one year.
6. HbA1c values (at screening) more than 5.7%
7. Subjects who is 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.
Major illness in the past.
14. Subjects who donated 350 ml or more blood within 90 days
of screening visit.
15. Subjects who have received any investigational drug within
30 days of screening visit. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pharmacokinetic parameters (Cmax and AUC0-24h)
pharmacodynamic parameters (AUCGIR,0-24h, and GIRmax) |
pharmacokinetic parameters- 0-24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare the pharmacokinetic
and pharmacodynamic profile as well as assess safety and local
tolerability of the two insulin formulations |
Visit 4 (Follow up visit) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/10/2017 |
| Date of Study Completion (India) |
03/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study yet to be inititated |