None listed
Conditions
Interventions
Intervention1: Glaritus: each Arm subjects will be exposed to 4 clamps and dose 2 single dose of both drug.
SC route of administeration
Control Intervention1: LANTUS: The dose of both formulations is
Sponsors
Wockhardt BIO AG
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.
Exclusion criteria
Exclusion criteria: Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT 2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal). History/presence of disorder related to CVS, CNS, Respiratory tract, GIT, Endocrinology, Haematology, Immunological or any other systemic disorder including any serious systemic infectious disease, as judged by the Investigator. History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, gross anaemia (or subject with haemoglobin level 12.5 gm/dl at screening) or hemoglobinopathy will not be eligible to participate in the trial. History of alcohol or drug abuse in the past five years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To obtain estimates of mean and variability of pharmacokinetic parameters (Cmax and AUC0-24h) and pharmacodynamic parameters (AUCGIR 0-24h and GIRmax) for Wockhardtâ??s long acting human recombinant insulin analog Glargine (Glaritus) and compare with the reference Lantusï?? in healthy subjects.Timepoint: The statistical analysis will be performed on log transformed area under the concentration-time curve from dosing time to last measurement time AUC0-24h peak insulin activity Cmax AUCGIR 0-24h and GIRmax for Wockhardt Insulin Glaritus Test and Lantus | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate average bioequivalence in the pharmacokinetic (PK) endpoints of Glaritus to Lantusï?? as well as assessing safety and local tolerability of the two insulin preparations.Timepoint: PD endpoints namely logtransformed area under the GIR time curve AUCGIR 0 24h and GIRmax for Wockhardts Insulin Glaritus and Lantus | — |
Countries
India
Contacts
Public ContactDr Sridhar Yeshamaina
Veeda Clinical Research Pvt. Ltd
Outcome results
None listed