CTRI/2021/09/036601已完成未知
A Randomized, Single Center, Double Blind, Two-Period, CrossoverGlucose Clamp Study to test for bioequivalence between twoRecombinant Human Insulin Analogues - Wockhardtâ??s BiphasicInsulin Aspart Injection (30/70) and NovoMix® 30, in HealthySubjects
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 14
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
- •Subjects weight within the normal range according to normal
- •values for the Body Mass Index (18.5 to 27.0 kg/m2, inclusive)
- •with minimum of 50 kg weight.
- •Subjects with normal health as determined by medical history,
- •clinical examination and laboratory examinations within the
- •clinically acceptable normal range.
- •Subjects having clinically acceptable 12-lead electrocardiogram
- •Subjects having clinically acceptable chest X-Ray (PA view).
- •Non-smoker, defined as no nicotine/tobacco consumption for last
- •six months.
排除标准
- •Hypersensitivity to Insulin or related class of drugs.
- •History or presence of significant cardiovascular, pulmonary,
- •hepatic, renal, gastrointestinal, endocrine, immunological,
- •dermatological, neurological or psychiatric disease or disorder.
- •Subjects with hemoglobin levels <12.5 gm/dl at screening or hemoglobinopathy.
- •Any treatment which could bring about induction or inhibition of
- •hepatic microsomal enzyme system within 1 month of the study
- •History or presence of alcoholism or drug abuse in the past one year.
- •HbA1c values (at screening) >= 5.7%.
研究者
相似试验
已完成
1 期
Bio-equivalence study of Biphasic Insulin Aspart Injection (30/70)CTRI/2023/02/050076Wockhardt Bio AG56
已完成
不适用
BA/BE trials between two recombinant human bi-phasic insuliCTRI/2015/05/005827Wockhardt Limited56
招募中
1 期
A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AD-6626 in Normal, Healthy Volunteers and Subjects Heterozygous for the Aldehyde Dehydrogenase 2*1/*2 Genetic Variant With and Without Alcohol AdministratioThis study is for healthy volunteers. The intended use of the investigational product is the treatment of Fanconi AnemiaHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersBlood - Haematological diseasesACTRN12615000056594ucleus Network64
招募中
不适用
A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of AD-6626 in Normal, Healthy Volunteers and Subjects Heterozygous for the Aldehyde Dehydrogenase 2*1/*2 Genetic Variant With and Without Alcohol AdministratioThis study is for healthy volunteers. The intended use of the investigational product is the treatment of acute alcohol intoxicationOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)ACTRN12614001333606Aldea Pharmaceuticals90
已完成
1 期
Bioequivalence and bioavailability study on InsuliCTRI/2017/08/009251Wockhardt Pvt Ltd50