Comparative pharmacokinetic and Pharmacodynamic trial of Wosulin R Insulin Injection (in comparision with Human Actrapid HM penfil insulin injection) in healthy human adult volunteers
- Registration Number
- CTRI/2015/05/005801
- Lead Sponsor
- Wockhardt Ltd India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 48
1.Healthy male subjects aged between 18 and 45 years,including both
2.Subjects with Body Mass Index (18.0 - 27.0 kg/m2), both inclusive with minimum of 45 kg Weight
3.Healthy subject, as determined by personal medical history, clinical examination and laboratory examinations
4.Subjects having clinically acceptable 12lead ECG.
5.Subjects having clinically acceptable chest X-Ray (PA view).
6.Have a negative urine screen for drugs of abuse [including amphetamine, barbiturate, benzodiazepines, marijuana (THC), cocaine, and morphine (opiate)].
7.Have a negative alcohol breath analysis.
8.Subjects should be non-smokers
9.Subjects without any evidence of impaired glucose tolerance in 2 hours OGTT performed during screening.
10.Subjects willing to adhere to the protocol requirements and to provide written informed consent for study participation.
1.Hypersensitivity to Insulin or related class of drugs.
2.History or presence of significant asthma (except mild asthmatic patients) urticaria or other allergic reactions including severe anaphylactic reaction.
3.History of deep vein thrombosis as judged by investigator
4.Subject with history or presence of congestive cardiac failure (NYHA class-III or IV) or acute myocardial infarction at any time in past or history of angina pectoris within last 12 months
5.Subjects with past/present history of any systemic disease related to Cardiovascular/ Respiratory/Hematology/Gastrointestinaltract/UTI/Endocrinology/UTI/ CNS /Metabolic Disorder.
6.Presence of diabetic complications such as unstable proliferative retinopathy or maculopathy requiring acute treatment within last 6 months and/or severe neuropathy (esp. autonomic neuropathy) as judged by investigator
7.History of mental retardation
8.Presence of intercurrent infection or any serious systemic infection during last 30 days prior to administration of first dose of trial drug.
9.Presence of clinically significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
10.History or presence of cancer.
11.Subject with any clinically significant illness, which has direct confounding effect on the trial outcome or pose risk to the subject in administering the trial drug as judged by the investigator.
12.Subject with anemia (Hb level lessthan 11 gm %) or hemoglobinopathy as detected by peripheral smear examination
13.Subjects with clinically significant abnormal hematology and biochemistry screening tests as judged by the investigator. In particular, subjects with elevated liver enzymes (AST or ALT 2 times the upper limit of normal) or impaired renal function (elevated S. Creatinine values above the 1.5 times upper limit of normal) will not be allowed to enter the trial. Subjects with clinically abnormal TSH as judged by the investigator will be excluded from the study.
14.Subjects with clinically abnormal 12 lead electrocardiogram (ECG) and chest X Ray (P/A view).
15.Subjects who have positive urine screen test for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
16.Subjects with positive alcohol breath test
17.Subjects with Hepatitis B or C or HIV positive
18.Subject who is pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
19.History or presence of significant alcoholism or drug abuse in the last one year.
20.Presence of significant smoking (more than 10 cigarettes or beedis/day) or consumption of tobacco products more than 10 sachets) or unable to refrain from smoking or tobacco products consumption during in house period.
21.Subjects who have participated previously in this trial or participated in other trial within last 30 days
22.Use of systemic corticoids in last 90 days or chronic steroid therapy
23.Use of any medications that may interfere with glucose metabolism or liver function or trial outcome as judged by investigator
24.Subjects who have taken any treatment, which could bring about induction or inhibition of hepatic microsomal enzyme system within last 30 days of the first dose administration of trial drug.
25.Difficulty with donating blood.
26.Donation
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK-Primary Endpoints: <br/ ><br>AUC INS 0-12 h, Cmax INS, <br/ ><br> <br/ ><br>PD-Primary Endpoints: <br/ ><br>AUC GIR 0-12 h, GIR max, <br/ ><br>Timepoint: Serial PK blood samples (each sample of 4 ml) for determination of serum Insulin and C-Peptide will be drawn at -0.17 <br/ ><br>hours pre-dose, 0.5, 01.00, 01.50, 02.00, 02.25, 02.50, 02.75, 03.00, 03.25, 03.50, 03.75, 04.00, 04.25, 04.50, 04.75, 05.00, 05.25, 05.50, 06.00, 06.50, 07.00, 08.00, 09.00, 10.00 and 12.00 <br/ ><br>hours post dose in each period (total 26 blood samples).
- Secondary Outcome Measures
Name Time Method PK-Secondary Endpoints: <br/ ><br>AUC INS 0-4 h, AUC INS 0-6 h, AUC INS 0-12 h, AUC INS 0-12 h, AUC INS 0-â?? h , Tmax INS, t1/2 INS, and elimination rate constant (ï?¬z) <br/ ><br> <br/ ><br>PD-Secondary Endpoints: <br/ ><br>AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h and tGIRmax <br/ ><br>Timepoint: Serial PK blood samples (each sample of 4 ml) for determination of serum Insulin and C-Peptide will be drawn at -0.17 <br/ ><br>hours pre-dose, 0.5, 01.00, 01.50, 02.00, 02.25, 02.50, 02.75, 03.00, 03.25, 03.50, 03.75, 04.00, 04.25, 04.50, 04.75, 05.00, 05.25, 05.50, 06.00, 06.50, 07.00, 08.00, 09.00, 10.00 and 12.00 <br/ ><br>hours post dose in each period (total 26 blood samples).