NCT03309566已完成4 期
Bioequivalence Study of Efavirenz, Emtricitabine and Tenofovir in Healthy Volunteers, After Administering a Single Dose of a Fixed Dose Combination of the Test Formulation With Respect to the Reference Product, Atripla ® From Gador S.A
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Bioequivalence study of two formulations containing a fixed dose combination of 600 mg Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets under a single-dose, two-way crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects between 18 and 55 years. Subjects with body mass index (BMI) between 19 and 27 kg / m². Subjects whose complementary tests (ECG, blood and urine) are within normal and / or clinically insignificant according to the judgment of the investigator.
- •Subjects with systolic blood pressure between 110 mmHg and 139 mmHg; diastolic pressure between 70 mmHg and 89 mmHg; heart rate between 50 and 90 beats per minute.
- •Subjects who signed informed consent.
排除标准
- •Background of clinically significant allergies (except untreated asymptomatic seasonal allergies), drug hypersensitivity and / or hypersensitivity to any component of the formulations studied.
- •Drop of more than 20 mmHg in systolic blood pressure or more than 10 mmHg diastolic pressure in the first 3 minutes of postural change.
- •Active smoker more than 10 cigarettes / day. Pregnant or lactating women. Current clinical evidence of severe digestive disorders, surgery of the digestive tract (except appendectomy).
- •Current clinical evidence of kidney disease. Current evidence of liver disorders Current clinical evidence of respiratory and heart diseases. The presence of diabetes mellitus, thyroid dysfunction or other endocrine disorder.
- •Evidence of gastroduodenal disease. Current presence of any malignancy. History of abuse or addiction to drugs or alcohol during the past three years. Participation in a clinical trial within the last three months. Use of any drug within fourteen days before the start of the study. Subject donated or suffered blood loss during the last twelve weeks before the start of the study, or intends to donate blood within three months of the completion of the study.
- •Excessive drinking of tea, cocoa, mate, coffee and / or beverages containing caffeine (> 5 cups / day) or wine (> 0.5 L / day) or alcohol (> 50 ml / day).
- •ECG abnormalities. Positive serology for HIV, hepatitis B or hepatitis C.
研究组 & 干预措施
Test - Reference
Experimental
A new formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) followed by a branded formulation (R).
干预措施: Efavirenz, tenofovir disoproxil fumarate and emtricitabine (Drug)
Reference - Test
Experimental
A branded formulation (R) followed by a new formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T).
干预措施: Efavirenz, tenofovir disoproxil fumarate and emtricitabine (Drug)
结局指标
主要结局
Cmax
时间窗: 192 hours
Maximum plasma concentration
AUC
时间窗: 192 hours
Area under the curve
次要结局
- Adverse events(192 hours)
研究者
研究点 (1)
Loading locations...
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