CTRI/2014/01/004309已完成1 期
A Phase 1, Three-Part, Three-Period, Open-Label, Randomized, Single Dose, Crossover Interaction Study, in Healthy Male Subjects to Investigate the Potential for a Pharmacokinetic Drug-Drug Interaction After Co-Administration of DS-5565 and Metformin
Daiichi Sankyo Development Limited0 个研究点目标入组 15 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
- 15
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. Healthy Males between 18 & 55 years of age, both inclusive
- •2. BMI of 18.5 to 30.0 kg per meter sq. inclusive
- •3. Negative urine test for drugs of abuse at screening and on Day -1 of each period
- •4. Subjects should agree to use a condom and spermicide during sexual intercourse from first dose until 90 days after last dose
- •5. Negative alcohol test on Day -1 of each period
- •6. Good Health (physical exam, medical history, lab reports, ECG etc.)
- •7. Willingness to give written ICF
排除标准
- •1. Clinically relevant abnormality in medical history,physical findings, ECG, or laboratory values that could interfere with the objectives of the study or the safety of the volunteer.
- •2. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteerâ??s participation in the study or make participation unnecessarily hazardous.
- •3. History of impaired hepatic, respiratory, or renal function; history of diabetes mellitus, coronary heart disease, or any psychotic mental illness.
- •4. History of clinically relevant dizziness or vertigo, or known inner ear problems leading to dizziness or vertigo.
- •5. History of tremor and any neurological disease.
- •6. Surgery (eg, stomach bypass) or medical condition that might affect absorption of medicines.
- •7. Presence or history of severe adverse reaction to any drug (except penicillin) or a history of sensitivity to besylate salts, benzenesulfonic acid, pregabalin (Lyrica®), gabapentin (Neurontin®), or metformin.
- •8. Blood haemoglobin (Hb) concentration 8.1
- •mmol/L (13.0 g/dL).
- •9. Subject smokes more than 10 cigarettes or
- •equivalent per day, and if a smoker, would not be
- •able to abstain from smoking during their period of residence in the Clinical Unit.
- •10. Use of any prescribed or over-the-counter (OTC) drugs, including vitamins and herbal remedies, in the 2 weeks prior to dose administration (exceptions: paracetamol up to 3 g per day and aspirin up to 1.5 g per day).
- •11. Concomitant use of medications known to be strong cytochrome P450 (CYP) inducers or inhibitors within 21 days prior to study admission.
- •12. Consumption of grapefruit, grapefruit juice,
- •pomelos, Seville oranges or St. Johnâ??s wort within 21 days prior to study admission and during confinement.
- •13. Positive serology for HBsAg, anti-HCV and/or anti-HIV 1 or 2.
- •14. Loss of more than 450 mL blood during the 3
- •months before the study (eg, as a blood donor).
- •15. Participation in another clinical study with
- •investigational drug/device within the 3 months
- •prior to administration of the study drug in this
研究者
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