None listed
Conditions
Interventions
Intervention1: Wockhardts Insulin Aspart Injection
(100 IU/ml) 3 ml cartridges of Wockhardt Ltd.: Wockhardts Insulin Aspart Injection will be administered, at 0.3IU/Kg
subject body weight.
Control Int
Sponsors
Wockhardt Bio AG
Wockhardt Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects weight within the normal range according to normal values for the Body Mass Index (18.5 to 27.0 kg/m 2, inclusive) with minimum of 50 kg weight. 2. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range. 3. Non-smoker, defined as no nicotine/tobacco consumption for last six months. 4. Have a negative urine screen for drugs of abuse. 5. Have a negative alcohol breath analysis.
Exclusion criteria
Exclusion criteria: 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. Subjects with hemoglobin levels 4. History or presence of alcoholism or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: PK: AUC0-10h and Cmax PD: AUCGIR0-10h and GIR maxTimepoint: 10hr from dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints: AEs, hematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerabilityTimepoint: Follow- up visit (10 days within the last dosing visit);Secondary Endpoints: PK endpoints: AUC0-1h, AUC0-2h, AUC0-6h, AUC0-infinity, tmax, t12 and elimination rate constant (Az) PD endpoints: AUCGIR0-1h, AUCGIR0-2h, AUCGIR0-6h, and tGIRmax Timepoint: 6 hr from dosing | — |
Countries
India
Contacts
Public ContactDr Mushtaque Mastim
Wockhardt Pvt Ltd
Outcome results
None listed