CTRI/2021/09/036637尚未招募1 期
A Phase 1, double-blind, randomized, placebo controlled, Parallel study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of MKP 10241 Suspension administered orally in healthy adult, human, male subjects.
试验速览
- 阶段
- 1 期
- 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
- Interventional
入排标准
入选标准
- •1. Subjects aged between 18 and 55 years (both inclusive).
- •2. Subjects weight within normal range according to normal values for Body Mass Index (18.5 to 30.0 kg/m2 (both inclusive)) with minimum of 50 kg weight.
- •3. Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable reference range.
- •4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •5. Subjects having clinically acceptable chest X-Ray (PA view), if taken.
- •6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •7. Subjects having negative alcohol breath test or urine alcohol
- •8. Subjects should be non-smokers and non-alcoholic
- •9. Subjects willing to adhere to the protocol requirements and to
- •provide written informed consent.
- •10. For male subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) Condom with spermicide, Condom with
- •diaphragm, or abstinence or subjects should also not donate
- •sperm during this time.
排除标准
- •1. History or presence of significant cardiovascular (e.g.
- •tachyarrhythmia or ischemic heart disease or congestive heart
- •failure), pulmonary, hepatic, renal, gastrointestinal, endocrine,
- •immunological, dermatological, neurological or psychiatric
- •disease or disorder.
- •2. Use of any treatment which could bring about induction or
- •inhibition of hepatic microsomal enzyme system within 30 days
- •prior to admission of period 01.
- •3. Presence of significant alcoholism or drug abuse.
- •4. History or presence of asthma, urticaria or other significant
- •allergic reactions.
- •5. History or presence of significant gastric and/or duodenal
- •ulceration.
- •6. History or presence of significant thyroid disease, adrenal
- •dysfunction, organic intracranial lesion such as pituitary tumor.
- •7. History or presence of cancer or basal or squamous cell
- •8. History or presence of narrow angle glaucoma.
- •9. Difficulty with donating blood.
- •10. Use of any prescribed medication during the last one month or
- •OTC medication (including vitamins and herbal remedies)
- •during last 30 days prior to dosing in period 01.
- •11. Major illness within past 3 months.
- •12. Volunteer who have donated blood (1 unit) or participation in a
- •drug research study within past 90 days prior to the first dose of
- •the study drug.
- •13. Consumption of xanthine-containing products, tobaccocontaining
- •products or alcohol within the 48 hours prior to
- •admission in period 01.
- •14. Consumption of grapefruit or grapefruit juice within the 72
- •hours prior to admission in period 01.
- •15. Positive screening test for any one or more: HIV, Hepatitis B
- •and Hepatitis C.
- •16. Subjects who have been on an abnormal diet (for whatever
- •reason) during the four weeks preceding the study.
- •17. History or presence of significant easy bruising or bleeding.
- •18. History or presence of significant recent trauma.
研究者
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