CTRI/2015/05/005801Other未知
A double-blind, randomized, single dose, two-period, two-way crossover bioequivalence study between two Recombinant DNA human soluble Insulin Formulations - Wockhardtâ??s rDNA human regular Insulin Injection (Wosulin R) 100 IU/mL with Actrapid® HM Penfill® (Regular, Human Insulin injection [rDNA origin] IP) 100 IU/mL, 3.0 mL of Imported by: Novo Nordisk India Private Limited and Manufactured by: Novo Nordisk Producao Farmaceutica do Brasil Ltda. Brazil 39404004, INDIA in healthy, adult, male subjects under fasting condition. - PK PD Trial
Wockhardt Ltd India0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- 入组人数
- 48
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
- •1.Healthy male subjects aged between 18 and 45 years,including both
- •2.Subjects with Body Mass Index (18.0 - 27.0 kg/m2), both inclusive with minimum of 45 kg Weight
- •3.Healthy subject, as determined by personal medical history, clinical examination and laboratory examinations
- •4.Subjects having clinically acceptable 12lead ECG.
- •5.Subjects having clinically acceptable chest X-Ray (PA view).
- •6.Have a negative urine screen for drugs of abuse [including amphetamine, barbiturate, benzodiazepines, marijuana (THC), cocaine, and morphine (opiate)].
- •7.Have a negative alcohol breath analysis.
- •8.Subjects should be non-smokers
- •9.Subjects without any evidence of impaired glucose tolerance in 2 hours OGTT performed during screening.
- •10.Subjects willing to adhere to the protocol requirements and to provide written informed consent for study participation.
排除标准
- •1.Hypersensitivity to Insulin or related class of drugs.
- •2.History or presence of significant asthma (except mild asthmatic patients) urticaria or other allergic reactions including severe anaphylactic reaction.
- •3.History of deep vein thrombosis as judged by investigator
- •4.Subject with history or presence of congestive cardiac failure (NYHA class-III or IV) or acute myocardial infarction at any time in past or history of angina pectoris within last 12 months
- •5.Subjects with past/present history of any systemic disease related to Cardiovascular/ Respiratory/Hematology/Gastrointestinaltract/UTI/Endocrinology/UTI/ CNS /Metabolic Disorder.
- •6.Presence of diabetic complications such as unstable proliferative retinopathy or maculopathy requiring acute treatment within last 6 months and/or severe neuropathy (esp. autonomic neuropathy) as judged by investigator
- •7.History of mental retardation
- •8.Presence of intercurrent infection or any serious systemic infection during last 30 days prior to administration of first dose of trial drug.
- •9.Presence of clinically significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •10.History or presence of cancer.
- •11.Subject with any clinically significant illness, which has direct confounding effect on the trial outcome or pose risk to the subject in administering the trial drug as judged by the investigator.
- •12.Subject with anemia (Hb level lessthan 11 gm %) or hemoglobinopathy as detected by peripheral smear examination
- •13.Subjects with clinically significant abnormal hematology and biochemistry screening tests as judged by the investigator. In particular, subjects with elevated liver enzymes (AST or ALT 2 times the upper limit of normal) or impaired renal function (elevated S. Creatinine values above the 1.5 times upper limit of normal) will not be allowed to enter the trial. Subjects with clinically abnormal TSH as judged by the investigator will be excluded from the study.
- •14.Subjects with clinically abnormal 12 lead electrocardiogram (ECG) and chest X Ray (P/A view).
- •15.Subjects who have positive urine screen test for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •16.Subjects with positive alcohol breath test
- •17.Subjects with Hepatitis B or C or HIV positive
- •18.Subject who is pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
- •19.History or presence of significant alcoholism or drug abuse in the last one year.
- •20.Presence of significant smoking (more than 10 cigarettes or beedis/day) or consumption of tobacco products more than 10 sachets) or unable to refrain from smoking or tobacco products consumption during in house period.
- •21.Subjects who have participated previously in this trial or participated in other trial within last 30 days
- •22.Use of systemic corticoids in last 90 days or chronic steroid therapy
- •23.Use of any medications that may interfere with glucose metabolism or liver function or trial outcome as judged by investigator
- •24.Subjects who have taken any treatment, which could bring about induction or inhibition of hepatic microsomal enzyme system within last 30 days of the first dose administration of trial drug.
- •25.Difficulty with donating blood.
- •26.Donation
研究者
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