Study to evaluate PK PD trial of Soluble Insulin Injection R 40 IU/m
- Registration Number
- CTRI/2018/03/012684
- Lead Sponsor
- nichem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Normal healthy human adult male volunteers between 18-45 years (both ages inclusive) of age, who have given written informed consent and are willing to participate in the study.
Volunteer having Body Mass Index of 18.50 to 24.90 Kg/m2 (both inclusive).
Volunteer with no evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study and during at the time of check-in of each period.
Volunteer whose pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his/her participation in the study.
Volunteer with negative test for alcohol, drugs of abuse, hepatitis B & C and who is negative or non-reactive for antibodies to HIV 1 and 2 and RPR.
Volunteer having a 12 lead ECG recording within normal limits.
Volunteer with normal chest X-ray taken within 6 months prior to the day of dosing of period 1.
Volunteer with normal renal function.
Volunteer will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
Volunteer should be non-smokers and without a history of alcohol.
Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT)
Volunteer who has hypersensitivity to Insulin or related class of drugs.
Volunteer who has family history of diabetes mellitus.
Volunteer with history or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
More specifically, volunteer with history or presence of significant:
History of Alcohol or drug abuse.
History of smoking, even single cigarette, bidis or any other form.
Asthma, urticaria or other allergic type reactions after taking any medication.
Clinically significant illness within 4 weeks before the start of the study.
History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
History of vascular collapse.
Volunteer who is scheduled for surgery any time during study or within 07 days after study completion.
Volunteer with history of difficulty in donating blood
Volunteer who, through completion of any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.
Volunteer who has taken prescription medication or over-the-counter products (including vitamins and products from natural origin e.g. St. Johnâ??s Wort) within 14 days prior to administration of IP in period 1, including topical medication meant for systemic absorption.
Volunteer who was hospitalized within 28 days prior to administration of the study medication.
Volunteer who has unsuitable veins for repeated venipuncture.
Volunteer who has Potassium level < 3.5 mmol/L.
Any abnormal laboratory value or physical finding which may interfere with the interpretation of test results or cause a health hazard for the volunteer if he participates in the study.
Volunteer having evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial.
Volunteer who has:
Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
Use of systemic corticosteroids, monoamine oxidase (MAO) inhibitors, prostaglandin blockers, systemic non-selective beta-blockers, growth hormones
Any use of non-steroid anti-inflammatory drugs (NSAIDs) except for low-dose Aspirin is not allowed within 7 days prior to dosing and on the dosing day
Use of any insulin product in the past
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary pharmacokinetic parameters: AUC0-t & Cmax <br/ ><br> <br/ ><br>Primary Pharmacodynamic parameters: GIR-AUC0-t & GIRmaxTimepoint: PK samples: A total of 28 PK blood samples (each sample of 6 ml)for determination of insulin & C-peptide will be drawn at at -00.50, -00.33 -00.17 hrs pre-dose 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.25, 03.50, <br/ ><br>03.75, 04.00, 04.25, 04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 10.00 and 12.00 post dose. <br/ ><br> <br/ ><br>PD samples: A total of 147 (1Ã?0.3 mL) blood samples will be collected every 5 minutes from the time of dosing till 12 hours post dose <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Secondary pharmacokinetic parameters: AUC0-4, AUC0-6, AUC0-12, AUC4-12, AUC6-12, AUC0-inf, Tmax, t1/2 & Kel <br/ ><br> <br/ ><br>Secondary Pharmacodynamic parameters: Time to onset of action & TGIRmaxTimepoint: PK samples: A total of 28 PK blood samples (each sample of 6 ml)for determination of insulin & C-peptide will be drawn at at -00.50, -00.33 -00.17 hrs pre-dose 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.25, 03.50, <br/ ><br>03.75, 04.00, 04.25, 04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 10.00 and 12.00 post dose. <br/ ><br> <br/ ><br>PD samples: A total of 147 (1Ã?0.3 mL) blood samples will be collected every 5 minutes from the time of dosing till 12 hours post dose <br/ ><br> <br/ ><br>