NCT03478436已完成1 期
Pharmacokinetics of DFD-09 (Doxycycline) Capsules, 40 mg in Skin of Healthy Volunteers Under Fed and Fasting Conditions - an Exploratory Microdialysis Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This study explored the impact of food on skin and plasma pharmacokinetics of doxycycline
详细描述
Sub-antimicrobial dose doxycycline is approved for the treatment of rosacea. This work investigated the pharmacokinetics of doxycycline in skin and plasma of fed and fasting healthy volunteers receiving a 14-day treatment course with once daily 40 mg doxycycline. Dermal measurements were performed by means of in vivo microdialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator
- •Signed written informed consent prior to inclusion in the study
- •18-45 years old inclusive
- •BMI: 18.5 to 30 kg/m2
- •SBP: 100-139 mmHg
- •DBP: 55-89 mmHg
- •PR: 55-100 bpm (measured after 5 min of rest, sitting position)
- •ability to comprehend the full nature and purpose of the study, including possible risks and side effects
- •ability to co-operate with the Investigator and to comply with the requirements of the entire study
- •availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
排除标准
- •Any clinically relevant abnormalities in ECG (12 leads)
- •Any clinically relevant abnormal physical findings
- •Any clinically relevant abnormal laboratory values indicative of physical illness
- •Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug or to tetracyclines in general
- •History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- •Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
- •Any psychiatric illnesses
- •Presence of any skin condition that would interfere with the placement of microdialysis probes
- •Any dermatological drug therapy on the surface of both thighs within 14 days before study day 1 of this study
- •Use of any medication(including OTC) within 1 week prior to study day 1
- •Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort) within 1 month prior to study day 1
- •Participation in another clinical study investigating another IMP within 1 month prior to study day 1
- •Blood donations within 1 month prior to study day 1 or planned within 1 month after the last study-related blood draw
- •History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
- •other objections to study participation in the opinion of the Investigator
研究组 & 干预措施
fed group
Other
14 once daily oral doses of doxycycline 40 mg, preceded by a standardized high-fat, high-calorie breakfast
干预措施: Doxycycline (Drug)
fasting group
Other
14 once daily oral doses of doxycycline 40 mg in fasting conditions (no food allowed 8 hours prior to dosing)
干预措施: Doxycycline (Drug)
结局指标
主要结局
AUC0-t
时间窗: at day 14
mg∙h/L
次要结局
未报告次要终点
研究者
Markus Zeitlinger
Assoc. Prof. Priv.-Doz. Dr.
Medical University of Vienna
研究点 (1)
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