None listed
Conditions
Interventions
Intervention1: Wockhardt s Biphasic Insulin Aspart Injection (30 by 70): Each subject will be randomized to receive single subcutaneous injection of either of the trial drugs on two separate dosing vi
Sponsors
Wockhardt limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects aged between 18 and 45 years (both inclusive). 2. Subjects weight within the normal range according to normal values for the Body Mass Index (18.5 to 27.0 kg per hr, inclusive) with minimum of 50 kg weight. 3. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range. 4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG). 5. Subjects having clinically acceptable chest X-Ray (PA view). 6. Non-smoker, defined as no nicotine or tobacco consumption for last six months. 7. Have a negative urine screen for drugs of abuse. 8. Have a negative alcohol test. 9. Subjects willing to adhere to the protocol requirements. 10. Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening. 11. Subject agrees 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 to not donate sperm during this period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
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 less than 12.5 gm per dl at screening or hemoglobinopathy. 4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting. 5. History or presence of alcoholism or drug abuse in the past one year. 6. HbAlc values (at screening) greater than or equal to 5.7%. 7. Subjects who are 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. 13. Major illness in the past. 14. Subjects who donated 350 ml or more blood within 90 days. 15. Subjects who have received any investigational drug within 90 days from screening visit. 16. Use of prescription and non-prescription drugs, except routine vitamins, within 2 weeks prior to screening/randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test for bioequivalence based on the pharmacokinetic parameters ( C max and AUC O-12h ) of two Recombinant Human Insulin Analogues - Wockhardts Biphasic Insulin Aspart Injection (30 by 70) and NovoMix 30 in healthy adult male subjects.Timepoint: 0-12 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To test for bioequivalence based on the pharmacodynamic parameters (AUCGIR, 0 - 12h, & GIRmax) of two Recombinant Human Insulin Analogues- Wockhardts Biphasic Insulin Aspart Injection (30 by 70) & NovoMix 30 in healthy adult male subjects.Timepoint: 0-12 hours;To compare the pharmacokinetic & pharmacodynamic profile as well as assess safety & local tolerability of the two Recombinant Human Insulin Analogues.Timepoint: 0-12 hours | — |
Countries
India
Contacts
Public ContactRanjeet Gutte
Wockhardt limited
Outcome results
None listed