Diabetes mellitus. Diabetes mellitus Without complications
Conditions
Interventions
Administration of Insulin-Glargine (rDNA origin
100 u/ml
Basagine™) 0.2 units/Kg subcutaneous dose.
Treatment - Drugs
Basagine™) 0.2 units/Kg subcutaneous dose
Sponsors
Getz Pharma (Pvt) Limited
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: INCLUSION: Healthy male/female, Age:18 to 50 years, BMI: 18-26 Kg/m2, Fasting plasma glucose: <6.0 mmol/l (<108 mg/dl) or normal range and Non-smoker, non-alcoholic EXCLUSION: • Volunteers with any neuropathy, diabetes mellitus. • Any active allergic disease or a history of significant allergic disease. • Presence of renal, hepatic or gastrointestinal disease known to interfere with the drug absorption, distribution, metabolism or elimination with in last year. • Subject demonstrates protocol non-compliance (e.g. uncooperative attitude, & inability to finish study). • Participation in another study within last 2 months of 1st drug administration. • If donated blood within last 2 months preceding the study. • Age below 18 years and above 50yr. • Smoking within last 3 months prior to the drug administration and 6 hours after drug administration. • Ingestion of OTC drug (except Paracetamol) within last 14 days of 1st drug administration. • Participants with insufficient organ and/or bone marrow dysfunction. • Ingestion of investigational drug within 1 year prior to 1st drug administration. • Participants with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study. • Results of CBC, LFT, serum creatinine, fasting plasma glucose indicating significantly out of range and abnormal ECG. • Participants with any physical/mental disability • Subjects with known HIV, hepatitis B or hepatitis C infection, or autoimmune diseases. • History of major organ transplantation, new onset diabetes, unstable thyroid function. • Alcohol or drug abuse within the past year. • Known hypersensitivity to investigational drug • Positive drug of abuse test and alcohol test. • Intake of gutka, pan and any other thing containing nicotine 48 hours before and during study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of Inslin and C-peptide. Timepoint: 30 min, 15 min before and 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 22, 23, 24, 25 hours after. Method of measurement: Serum concentrations of Insulin and C-peptide would be measured through Chemiluminescence. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: Cmax, Tmax and AUC0-t. Timepoint: Pharmacokinetic (PK) parameter will be determined: Area under the curve to the last measurable concentration (AUC_ 0-t) will be calculated by the linear trapezoidal rule. C_max and t_max would also be recorded form the drug concentration vs time profile. Method of measurement: Pharmacokinetic (PK) parameter will be determined on the basis of measurement of exogenous and endogenous concentration of insulin; performed by means of model independent method using PPstat computer programs. | — |
Countries
Pakistan
Contacts
Public ContactMs. Ghousia Saba
Pharma Professional Services, Karachi, Pakistan
Outcome results
None listed