NL-OMON51616已完成不适用
Relative bioavailability study to investigate a potential interaction between dolutegravir (DTG) and tenofovir alafenamide fumarate/emtricitabine (F/TAF) administered as paediatric tablet formulations. - UNIVERSAL RBA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
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 64（—）
入选标准
- •1. Subject is at least 18 and not older than 55 years of age at the day of
- •2. Subject weighs at least 40 kg.
- •3. Subject has a BMI of 18.5-30 kg/m2, extremes included.
- •4. Subject is able and willing to sign the Informed Consent Form prior to
- •screening evaluations.
- •5. Subject is in good age-appropriate health condition as established by
- •medical history, physical examination, electrocardiography, results of
- •biochemistry, haematology and urinalysis testing within four weeks prior to day
- •1. Results of biochemistry, haematology and urinalysis testing should be within
- •the laboratory's reference ranges. If laboratory results are not within the
- •reference ranges, the subject is included based on the Investigator*s judgment
- •that the observed deviations are not clinically relevant. This should be
- •clearly recorded.
- •6. Subject has a normal blood pressure and pulse rate, according to the
- •Investigator*s judgment.
- •7. Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day
- •for at least 3 months prior to day 1.
排除标准
- •1. Positive HIV test.
- •2. Positive hepatitis B or C test.
- •3. Documented history of sensitivity/idiosyncrasy to medicinal products or
- •excipients.
- •4. Relevant history or current condition that might interfere with drug
- •absorption, distribution, metabolism or excretion.
- •5. Inability to understand the nature and extent of the study and the
- •procedures required.
- •6. Pregnant female (as confirmed by an hCG test performed less than 4 weeks
- •before day 1) or breast-feeding female. Female subjects of childbearing
- •potential without adequate contraception, e.g. hysterectomy, bilateral tubal
- •ligation, (non-hormonal) intrauterine device, total abstinence, double barrier
- •methods, or two years post-menopausal. They must agree to take precautions in
- •order to prevent a pregnancy throughout the entire conduct of the study.
- •7. Therapy with any drug (including herbal remedies, multivitamins, iron
- •supplements and calcium supplements) for two weeks preceding day 1, except for
- •acetaminophen.
- •8. Relevant history or presence of pulmonary disorders (especially COPD),
- •cardiovascular disorders, neurological disorders (especially seizures and
- •migraine), psychiatric disorders, gastro-intestinal disorders, renal disorders
- •(renal failure determined as an estimated Glomerular Filtration Rate (eGFR)
- •below 50 ml/min (MDRD-based)), hepatic disorders (Child-Pugh B or C), hormonal
- •disorders (especially diabetes mellitus), coagulation disorders.
- •9. History of or current abuse of drugs, alcohol or solvents.
- •10. Participation in a drug study within 60 days prior to day 1.
- •11. Donation of blood within 60 days prior to day 1.
- •12. Febrile illness within 3 days before day 1.
- •13. Co-worker of Radboud university medical center.
研究者
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