None listed
Conditions
Interventions
Intervention1: Biphasic Insulin Aspart (30/70): Trial products will be administered subcutaneously, at 0.3 IU/Kg body weight.(Single dose)
Control Intervention1: NovoMix® 30: Trial products will be a
Sponsors
Wockhardt Bio AG
Eligibility
Inclusion criteria
Inclusion criteria: Subjectâ??s weight within the normal range according to normal values for the Body Mass Index (18.50 to 27.00 kg/m2, both inclusive) with minimum of 50 kg weight. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range. Subjects having clinically acceptable 12-lead electrocardiogram (ECG). Subjects having clinically acceptable chest X-Ray (PA view). Non-smoker, defined as no nicotine consumption for last six months. 7. Have a negative urine screen for drugs of abuse {including amphetamine, barbiturate, benzodiazepines, marijuana (THC), cocaine, and morphine (opiate)}. Have a negative alcohol breath analysis. 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.) Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.
Exclusion criteria
Exclusion criteria: 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. 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A] Primary Endpoints: PK: AUC0-24 and Cmax PD: AUCGIR0-24, and GIR max Timepoint: schedule time for PK samples from dosing till 24 hours post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: PK endpoints: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h, AUC12-24h, AUC0-ï?¥, tmax, t½ and elimination rate constant (ï?¬z) PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,, AUCGIR6-12h, AUCGIR6-24h, AUCGIR12-24h and tGIRmax Safety endpoints: AEs, hematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability. Timepoint: upto 24hrs | — |
Countries
India
Contacts
Public ContactDr Mushtaque Mastim
Wockhardt Limited
Outcome results
None listed