A Phase I clinical trial to study the effect of two drugs, Insulin Glargine manufactured by BioGenomics limited and Lantus® by comparing pharmacokinetic and pharmacodynamic properties, safety and tolerability in healthy male volunteers.

Phase 1

Not yet recruiting

• Registration Number: CTRI/2022/09/045313
• Lead Sponsor: BioGenomics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Body Mass Index (18.50-24.90 kg/m2), Glucose Tolerance Test (OGTT), HbA1c <= 5.7, plasma glucose, creatinine clearance >80 mL/min, medical history, clinical examination including vital signs blood pressure, body temperature, radial pulse rate and respiratory rate, physical examination and systemic examination, Chest X-ray PA view

Exclusion Criteria

Hypersensitivity to exogenous insulin or any component of the product or related class of the drugs, . History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, urogenital, dermatological, neurological or psychiatric disease or disorder, History of hyperglycemia, History of hypoglycaemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of Insulin Glargine 100 U/mL of BioGenomics Limited and Lantus® (Insulin Glargine) 100 U/mL of Sanofi-Aventis in healthy, adult, human male subjects under fasting condition <br/ ><br>Timepoint: PK- 12: One pre- dose sample at 0.0 hrs and 11 post dose samples <br/ ><br> <br/ ><br> <br/ ><br>PD- 147: 3 pre-dose samples (-0.50, -0.33, -0.17 hrs) and 144 post dose samples (samples every 10 mins throughout the 24 hrs glucose clamp) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To assess and compare the safety and tolerability of subjects after single-dose administration of both Test and Reference products.Timepoint: Throughout the study