Open, Randomized, 3 Period Cross-over Design, in Healthy Volunteers to Compare the Pharmacokinetics Profiles of 3 Treatments: ISO 20, IBU 200 and IBU Plus ISO Combinations (200 + 20) Administered Per os as Single Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter: AUC 0-12
研究概览
简要总结
This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200 and IBU and ISO combinations (200 +20) given in single dose.
This study is being conducted to support the submission for new indication in treatment of the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular dystrophy.
详细描述
This trial is designed to define drug interactions following the combined administration of Isosorbide Dinitrate, a NO donor, and ibuprofen, NSAID, a through pharmacokinetics approach.
Both ibuprofen and Isosorbide Dinitrate were licensed worldwide. Ibuprofen is approved for use in adults and children; Isosorbide is approved for use in adults. Ibuprofen is currently used in pediatric patients as a first line anti-inflammatory and antipyretic agent. Consensus exists that among NSAIDs ibuprofen is the one endowed with less adverse effects (see note 66 of the Italian Drug Agency AIFA and MEA). No specific studies concerning safety and tolerability of ISDN in pediatric patients have been reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy free-living
- •Males between the age of 18 and 27
- •Normal ECG
- •Body Mass Index of 19.0-29.0 (Kg/m2)
- •Subject healthy in the opinion of the Investigator
- •Signed informed consent after verbal and written information
排除标准
- •Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
- •Any Gastrointestinal conditions which, in the opinion of the Investigator, may interfere with the absorption of the drug or render the subjects unable to take oral medication (gastric ulcer, peptic ulcer, stomach acid, frequent diarrhea, gastrointestinal surgery)
- •History of the following cardiac diseases SBP <120 mmHG or DBP < 80 mmHg
- •Platelet count < 100000/mm3
- •History of recurrent headache
- •History of ongoing or clinically relevant glaucoma
- •History of alcohol, drug or medication abuse within the past 2 years
- •Treatment with norepinephrine, acetylcholine and histamine
- •History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- •Participation in another study phase 1 with any investigational product within 6 months of screening
研究组 & 干预措施
Isosorbide Dinitrate 20 mg
Isosorbide Dinitrate 10 mg b.i.d
干预措施: Isosorbide Dinitrate (Drug)
Ibuprofen 200 mg
Ibuprofen 200 mg daily, capsule
干预措施: Ibuprofen (Drug)
Isosorbide dinitrate and Ibuprofen
Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily
干预措施: Ibuprofen and Isosorbide Dinitrate combination (Other)
结局指标
主要结局
Pharmacokinetic parameter: AUC 0-12
时间窗: At period I, II and III with 7 days intervals between periods
Area under the time-concentration curve (AUC 0-12) of IBU and ISO given concomitantly compared to AUCs of ISO alone and IBU alone. Time points: = at pre dose, 30, 60, 90, 120, 150, 180, 210, 240 min and 5, 6, 8, 10 and 12 hrs post dose
次要结局
- C max(At period I, II and III with 7 days intervals between periods)
- T max(At period I, II and III with 7 days intervals beteween periods)
- Adverse Events(9 days)
- Vital signs(9 days)