CTRI/2020/12/030079
Recruiting
Phase 1
A double-blind, randomized, single-center, two treatment, four period, two sequence, replicate crossover, euglycemic clamp study to demonstrate equivalence in the Pharmacokinetic and Pharmacodynamic properties of Insulin Glargine injection 100IU/mL of Stelis Biopharma and LANTUS® (Insulin Glargine injection 100 IU/mL of Sanofi Aventis) in healthy, adult, human subjects under fasting condition. - Nil
Stelis Biopharma Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Stelis Biopharma Pvt Ltd
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy adult human (both male and female) subjects aged between 21 to 55 years (both inclusive).
- •2\. Subjects have BMI between 18\.50 and 24\.90 kg/m2 (both inclusive) with minimum of 55 kg weight.
- •3\. Subject with Hemoglobin level \>\=12\.0 G%, Plasma glucose (FBG)75\-100 mg/dl. HbA1c \<\= 5\.5\.
- •4\. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range
- •5\. Subjects having clinically acceptable 12\-lead electrocardiogram (ECG).
- •6\. Subjects having clinically acceptable chest X\-Ray (PA view) whose XRay was taken not more than 6 months prior to the dosing of Period 01\. If report of X\-ray done within last 6 months is not available / Volunteer
- •having significant past history related to respiratory disease or clinical research physician / investigator found abnormal observations (crepts,rhonchi, wheezing etc.) on auscultation in respiratory system
- •examination then Chest X\-Ray (PA view) will be done during screening.
- •7\. Subjects having negative urine screen for drugs of abuse (including amphetamine, barbiturate, benzodiazepines, marijuana, cocaine, and morphine.
- •8\. Subjects having negative breath alcohol test.
Exclusion Criteria
- •1\. Hypersensitivity to exogenous insulin or any component of the product or
- •related class of the drugs.
- •2\. History or presence of significant cardiovascular, pulmonary, hepatic,
- •renal, gastrointestinal, endocrine, immunological, urogenital,
- •dermatological, neurological or psychiatric disease or disorder.
- •3\. Use of any treatment which could bring about induction or inhibition of
- •hepatic microsomal enzyme system within 30 days prior to dosing of
- •period 01\.
- •4\. History of hyperglycaemia (symptoms include nausea, vomiting,
- •drowsiness, flushed dry skin, dry mouth, increased frequency of
Outcomes
Primary Outcomes
Not specified
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