None listed
Conditions
Interventions
Intervention1: WOCKHARDTâ??S CONSEGNAâ?¢ - 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 inje
Sponsors
Wockhardt Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameters (Cmax and AUC0-24h) pharmacodynamic parameters (AUCGIR,0-24h, and GIRmax)Timepoint: pharmacokinetic parameters- 0-24 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| to compare the pharmacokinetic and pharmacodynamic profile as well as assess safety and local tolerability of the two insulin formulationsTimepoint: Visit 4 (Follow up visit) | — |
Countries
India
Contacts
Public ContactShraddha Tawade
Wockhardt Pvt Ltd
Outcome results
None listed