CTRI/2021/05/033411尚未招募未知
A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO TREATMENT, TWO-PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST FOR BIOEQUIVALENCE BETWEEN WOCKHARDTâ??S WOSULIN® 30/70 (100 IU/mL) {BIPHASIC ISOPHANE INSULIN INJECTION/ 70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (r-DNA ORIGIN)} AND HUMULIN® 70/30 (100 U/mL) {70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (rDNA origin)} IN HEALTHY SUBJECTS. - Clamp Study
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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.Male subjects aged between 18 and 45 years both inclusive.
- •2.Subjects weight within the normal range according to normal values for the Body Mass Index 18.5 to 27.0 kg per m2, inclusive with minimum of 50 kg weight.
- •3.Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- •4.Subjects having clinically acceptable 12 lead electrocardiogram during screening.
- •5.Subjects having clinically acceptable chest X Ray PA view.
- •6.Non-smoker, defined as no nicotine consumption for last six months.
- •7.Have a negative urine screen for drugs of abuse.
- •8.Have a negative alcohol breath analysis.
- •9.Subjects willing to adhere to the protocol requirements and are agreed for verbal and written consent to audio-visual recording of the discussion of consent process and agreed to provide the signed and dated informed consent before any trial related activities. Trial related activities are any procedure that would not have been performed during normal management of the subject.
- •10.Subjects with normal results of 2 hours Oral Glucose Tolerance Test performed at screening.
- •11.Subject agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from screening till 90 days following the last administration of the study drug and to not donate sperm during this period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary.
排除标准
- •1.Hypersensitivity to Insulin or related class of drugs.
- •2.History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •3.Subjects with hemoglobin levels less than 12.5 gm/dl at screening or hemoglobinopathy.
- •4.Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- •5.History or presence of significant alcoholism or drug abuse in the past one year.
- •6.HbA1c values at screening >= 5.7%
- •7.Subjects who are Hepatitis B or C or HIV or VDRL or RPR positive.
- •8.History or presence of significant asthma, urticaria or other allergic reactions.
- •9.History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •10.Known presence of cancer.
- •11.Family history of diabetes mellitus.
- •12.Difficulty in donating blood.
- •13.Major illness in the past.
- •14.Subjects who donated 350 ml or more blood within 90 days.
- •15.Subjects who have received any investigational drug within 90 days from screening visit.
- •16.Use of prescription and non-prescription drugs, except routine vitamins, within 2 weeks prior to screening till study completion.
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