PACTR201611001870300尚未招募未知
A Balanced, Randomized, Two Treatment, Two-Period, Two-Sequence Single Dose Crossover, Open-Label, Analyst Blind And Single Centre Bioequivalence Study Test Product; Tenofevek Of Danadams Pharmaceuticals Industry Ltd., Ghana And Reference Product; Viread (Gilead Sciences, Inc., CA, USA) In Healthy, Ghanaian Adult, Male, Human Participants Under Fasting Conditions
Danadams Pharmaceutical Company Limited0 个研究点目标入组 30 人开始时间: 2016年11月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- Male
入选标准
- •The participants with following criteria will be included into the study:
- •1. Healthy males within 18-35 years of age (both inclusive)
- •2. Weight at least 35 kg and BMI in the range of 18.5 ¿ 24.9 kg/m2 (both inclusive).
- •3. Normal health as determined by medical history and clinical examination, laboratory or other tests (mentioned in sections 8.4.II, 8.4.III) within normal range
- •4. Willingness to provide voluntary written informed consent to participate in the study, ability to comprehend the nature and purpose of the study
- •5. Willingness to comply with the requirement of the protocol including all the restrictions.
- •6. Availability of participant for the entire study period
排除标准
- •1. History of allergy or hypersensitivity to Investigational Product.
- •2. Abnormalities in vital signs (systolic blood pressure < 90 or > 140 mm Hg or diastolic blood pressure < 50 or > 90 mm Hg or heart rate < 50 bpm or > 100 bpm) at screening, at pre-entry and at pre-dose physical examination.
- •3. Clinically significant cardiovascular, gastrointestinal, liver, renal, pulmonary, haematological, neurological, endocrinal disease.
- •4. History of epilepsy or psychiatric or CNS disorder.
- •5. Any illness within 21days or hospitalized or a major illness within the 3 months prior to the first dosing.
- •6. Any other clinical condition, which may affect the absorption, distribution, biotransformation or excretion of the study drug. (eg. diarrhoea, vomiting in 3 days prior to or at dosing).
- •7. Use of any prescribed medication during last two weeks or OTC medical products during the last one week preceding the first dosing.
- •8. Participated in any other clinical investigation requiring repeated blood sampling/a blood donation program / have blood loss of more than 350 mL in the past three months.
- •9. History of consumption of alcohol for more than two years & drink more than two alcoholic drinks per day or consumed alcohol within 72 hours prior to first dosing [one drink is equal to one unit of alcohol (one glass wine, half pint beer, and one measure i.e. one fluid ounce of spirit)].
- •10. Smoke more than 10 cigarettes/day or Unable to abstain from smoking during the study.
- •11. Consumption of products containing xanthine & nicotine within 72 hours before dosing.
- •12. Intake of grapefruits or products containing grapefruits within 72 hours prior to receiving the dose of study medication in each period.
- •13. An unusual diet, for whatever reason (e. g. low-sodium or high protein) for four weeks prior to receiving the study medication.
- •14. Use of any recreational drug or a history of drug addiction.
- •15. Participation in any clinical study within the past 3 months.
- •16. History of difficulty in accessibility of veins in arms.
研究者
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