CTRI/2017/08/009251已完成1 期
A Randomized, Single Center, Double Blind, Two Treatment, Two-Period, Crossover Glucose Clamp Study To Test For Bioequivalence Between Wockhardtâ??s Consegnaâ?¢ - 30/70 (Bi Phasic Isophane Insulin 30/70 Injection 200 IU) and Mixtard® 30/70 (100 IU), In Healthy Subjects.
Wockhardt Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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.Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- •2. Subjects having clinically acceptable 12-lead
- •electrocardiogram (ECG).
- •3. Subjects having clinically acceptable chest X-Ray (PA view).
- •4. Non-smoker, defined as no nicotine consumption for last six months.
- •5.Have a negative urine screen for drugs of abuse (including amphetamine, barbiturate, benzodiazepines, marijuana (THC), cocaine, and morphine (opiate)).
- •6. Have a negative alcohol breath analysis.
- •7. 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.)
- •8. Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.
- •9. 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 not to 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
- •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
- •3. Subjects with hemoglobin levels 12.00 gm/dl at screening
- •or hemoglobinopathy will not be eligible for the study
- •4. Any treatment which could bring about induction or
- •inhibition of hepatic microsomal enzyme system within 1
- •month of the study drug administration
- •5. History or presence of significant alcoholism or drug abuse in
- •the past one year.
- •6. HbA1c values (at screening) more than 5.7%
- •7. Subjects who is Hepatitis B or C or HIV or VDRL 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
- •10. History or presence of cancer.
- •11. Family history of diabetes mellitus.
- •12. Difficulty in donating blood.
- •Major illness in the past.
- •14. Subjects who donated 350 ml or more blood within 90 days
- •of screening visit.
- •15. Subjects who have received any investigational drug within
- •30 days of screening visit.
研究者
相似试验
已完成
1 期
To compare PK, PD, safety and tolerability of recombinant human Insulin Aspart Mix 30(BioGenomics Ltd) vs NovoMix® 30 in male healthy volunteers.CTRI/2022/06/043169BioGenomics Ltd60
尚未招募
1 期
study to understand bio availability wockhardtâ??s wosulin® 30/70 and actraphane 30 , in healthysubjectsCTRI/2020/04/024787Wockhardt Bio AG
已完成
不适用
Bio-equivalence study of Biphasic Insulin Aspart Injection (30/70)CTRI/2021/09/036601Wockhardt Bio AG14
已完成
1 期
Bio-equivalence study of Biphasic Insulin Aspart Injection (30/70)CTRI/2023/02/050076Wockhardt Bio AG56
进行中（未招募）
1 期
A Single-Center, Randomized, Double-Blind, Double-Dummy Placebo Controlled, Cross-Over Study to Investigate the Next Morning Effects of Ramelteon (8mg), Zopiclone (7.5mg) and Placebo on Actual Driving Performance, Memory Functioning, Psychomotor Performance in Adults with Chronic InsomniaEUCTR2007-002875-15-NLTakeda30