A randomized, double blind, balanced, two treatment, two period, two sequence, single dose, crossover pharmacokinetic and pharmacodynamic bioequivalence study of Soluble Insulin Injection R 40 IU/mL of Unichem Laboratories Ltd., India with Huminsulin R 40 IU/mL of Eli Lilly and company (India) Pvt. Ltd in healthy human adult male subjects using Euglycemic clamp technique under fasting conditions.

nichem Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Ba/be

入排标准

入选标准

•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)

排除标准

•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

研究者

发起方

nichem Laboratories Limited

相似试验

已完成

1 期

A comparative pharmacokinetic and pharmacodynamic study of insulin aspart protamine suspension administered as subcutaneous injection in healthy subjects.

CTRI/2023/07/055238Mankind Pharma Limited, India36

已完成

不适用

PHARMACOKINETIC, PHARMACODYNAMIC BIOEQUIVALENCE STUDY ON VB70G(INSULIN GLARGINE INJECTION) 100 IU/ML - FASTING

CTRI/2022/08/044806Virchow Biotech Private Limited40

尚未招募

1 期

Comparative bioavailability/ bioequivalence study of Lutein formulations - Product C and Product D (Lutein 20 mg/capsule) supplementation in healthy, adult humans, after receiving high-fat, high-calorie breakfast.

CTRI/2018/08/015403Mr Abhijeet Morde

尚未招募

1 期

To Compare the bioavailability of Lutein formulations - Product A and Product B (Lutein 10 mg/Zeaxanthin 2 mg per capsule) supplementation in healthy, adult human subjects under fed conditions.

CTRI/2019/11/022082Mr Abhijeet Morde

尚未招募

1 期

Comparative bioavailability/ bioequivalence study of Lutein formulations - Product A and Product B (Lutein 20 mg/capsule) supplementation in healthy, adult humans, after receiving high-fat, high-calorie breakfast.

CTRI/2018/08/015507Mr Abhijeet Morde