NL-OMON36725已完成不适用
An Open-Label Two-Way Drug-Drug Interaction Study to Assess the Effect of Tenofovir on the Pharmacokinetics of BMS-790052 and the Effect of BMS-790052 on the Pharmacokinetics of Tenofovir in Healthy Subjects - BMS-790052/tenofovir drug-drug interaction study
Bristol-Myers Squibb0 个研究点目标入组 21 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Age: 18-49 years, inclusive
- •BMI: 18.0 - 32.0 kg/m2, inclusive
- •Women of child bearing potential should use adequate contraception (e.g., double barrier method) until at least 12 weeks after last dose of study medication
排除标准
- •- Any significant acute or chronic medical illness (especially renal disease).
- •- Current or recent (within 3 months of study drug administration) gastrointestinal disease indicated as clinically relevant by the Medical Investigator.
- •- Any major surgery within 4 weeks of study drug administration.
- •- Any gastrointestinal surgery that could impact upon the absorption of study drug.
- •- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 90 days of study drug administration.
- •- Blood transfusion within 90 days of study drug administration.
- •- Inability to tolerate oral medication.
- •- Inability to swallow oral medication in the form of tablets or capsules.
- •- Inability to be venipunctured and/or tolerate venous access.
- •- Smoking more than 5 cigarettes per day.
- •- History of renal disease including but not limited to acute renal failure and Fanconi syndrome.
- •- History of pathologic fracture or other significant risk factors for osteoporosis or bone loss.
- •- Recent (within 6 months of study drug administration) drug or alcohol abuse
- •- Any other sound medical, psychiatric and/or social reason as determined by the investigator.
- •- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- •- Positive urine screen for drugs of abuse.
- •- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen (HBsAg), HIV viral load or HIV-1, -2 antibody
- •- Serum creatinine > upper limit of normal (ULN).
- •- History of any significant drug allergy (such as anaphylaxis, hepatotoxicity or rash).
- •- Pregnancy or lactation (females only).
- •- Prisoners or subjects who are involuntarily incarcerated.
- •- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
研究者
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