None listed
Conditions
Interventions
Intervention1: Insulin Degludec Injection: Strength 3 mL: 300 IU Injection
Dose 0.4 units/kg weight (Single dose)
Control Intervention1: Insulin Degludec Injection (TRESIBA ): Strength 3 mL: 300 IU
Sponsors
Lupin Ltd
Mr Pramod V Kadam
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult human male and or female participants between 18 to 45 years of age including both and weight 50 Kg BMI 18.5 to 30.0 kgperm . Acceptable findings during registration and screening including medical history physical examination, laboratory evaluations 12 lead ECG and Chest X Ray postero anterior view. HbA1c levels within normal range. Normal range for OGTT. Values of laboratory parameters within normal range or clinically non significant as determined by the investigator or physician parameters for any of the following tests. Participants able to communicate effectively. Participants willing to give written informed consent and adhere to all the requirements of this protocol. Participants willing to abstain from all kinds of caffeine or xanthine containing foods or grapefruit or grapefruit juice from 72.00 hours prior to admission until the last post dose blood sample collection in each period. Participants should be non-smoker and non alcoholic.
Exclusion criteria
Exclusion criteria: Participants having a known history of contraindication or hypersensitivity e.g. anaphylaxis to Insulin or any of its related group of drugs will be excluded from the study. A history or presence of significant asthma urticaria or other allergic type reactions after taking aspirin or other NSAIDs. Severe rarely fatal anaphylactic like reactions to NSAIDs seizures diabetes migraine hypertension cardiovascular pulmonary neurological or psychiatric disease or disorder dermatological endocrine immunological hepatic renal hematopoietic gastrointestinal ongoing infectious diseases or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician. History or presence of gastrointestinal GI inflammation bleeding ulceration and perforation of the stomach small intestine or large intestine. History or evidence of exfoliative dermatitis Stevens Johnson syndrome SJS and toxic epidermal necrolysis TEN. Any known enzyme inducing or inhibiting drug taken within 14 days before the study. Participation in a drug research study within 90 days prior to dosing of this study Except for the participants who enrolled as a stand by for any other study and not dosed. Participants who have a history of severe hypoglycemic episodes. Participants who have a history of hypokalemia. Participants who have a history of orthostatic hypotension syncope or amaurosis. Blood loss or whole blood donation within 90 days prior to drug administration. Consumption of high caffeine more than 5 cups of coffee or tea per day. History of addiction to any recreational drug or drug dependence. An unusual or abnormal diet for whatever reason within 48.00 hours prior to admission of each period e.g. fasting due to religious reasons. History of dehydration from diarrhea, vomiting or any other reason within a period of 72.00 hours prior to study admission of each period. Positive results for drugs of abuse benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates in urine during the study admission of each period. Positive results for alcohol consumption test breath alcohol or urine alcohol during the study admission of each study period. Positive result for anti insulin antibody test. History of pre existing bleeding disorder. Difficulty with donating blood. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Pulse rate less than 60 beatsperminute or more than 100 beatsperminute. Use of any prescribed medication or OTC medicinal products during last two weeks preceding the first dosing. History of alcohol abuse and or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study. Female participants who is pregnant currently breast feeding. Female participants demonstrating a positive pregnancy test. Female participants who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate pharmacokinetic similarity of test and reference product in normal, healthy, adult, human subjects under fasting conditions.Timepoint: PK In study period pre dose samples at 00.50 00.17 and 00.00 before dosing 01.00 02.00 04.00 06.00 08.00 09.00, 10.00 11.00 12.00 14.00 16.00 24.00 36.0 48.00 72.00 96.00 and 120.00 hours post dose. PD Total 83 samples 00.17 TO 24.00 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of Test Product Insulin Degludec Injection 100 Units per mL in healthy adult, human participants using Euglycaemic clamp technique under fasting conditions.Timepoint: Pre-dose, 02.00, 05.00, 09.00, 12.00, 15.00, 25.00 and 33.00 hours and end of the study. | — |
Countries
India
Contacts
Public ContactDr Sowmya Bondalapati MD
Jeevan Scientific Technology Ltd
Outcome results
None listed