NCT01165840已完成4 期
Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers
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
- 37
- 试验地点
- 1
- 主要终点
- Serum Clearance
研究概览
简要总结
This study will find how weight affects the dosing of a drug called dapsone. Currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects, age >18 years, of all racial and ethnic origins.
- •Non-English speaking Spanish speakers will be included in the study.
- •We are recruiting 12 normal or underweight (BMI <25 kg/m2), 12 overweight or obese (BMI 25-40 kg/m2), and 12 extremely obese (BMI > 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / [height (in)]2 x 703). Half of each group will be male; the other half will be female.
排除标准
- •Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of dapsone on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of dapsone, so that the pregnancy and post-partum state would be a confounding variable.
- •Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
- •History of allergies to dapsone, sulfones, or sulfonamides.
- •Dapsone, sulfones, or sulfonamides are contraindicated for any reason.
- •Volunteers unwilling to comply with study procedures.
- •Current suspected or documented infection of any kind.
- •Volunteers with colon resection, gastric bypass, lap band, or any other conditions inhibiting gastric absorption of drug.
- •Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by PI.
- •Donation of 450 milliliters (ml) (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
- •Current use of zidovudine, amprenavir, rifabutin, rifapentine, or saquinavir.
- •Creatinine clearance < 70 ml/minute (min) as estimated by the Cockcroft-gault equation.
研究组 & 干预措施
Dapsone
Experimental
Dapsone 100 mg PO x 1 dose
干预措施: Dapsone (Drug)
结局指标
主要结局
Serum Clearance
时间窗: 72 hours
Serum clearance of dapsone
次要结局
未报告次要终点
研究者
Ron Hall
Associate Professor
Texas Tech University Health Sciences Center
研究点 (1)
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