Crossover Randomised Bioavailability Clinical Study Of A Single Dose Of Nifedipine Oral Solution From Laboratorio Reig Jofre S.A. Compared To Adalat(R) Capsules In Healthy Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve (AUC 0-24h)
研究概览
简要总结
Phase I, crossover, randomised, single dose, relative bioavailability clinical trial of a new oral solution of nifedipine compared to Adalat soft gelatine capsules in healthy female volunteers.
详细描述
The study was designed to compare the bioavailability of nifedipine new formulation specially designed to be used in pre-term labour management instead of anti-hypertensive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 to
- •Body weight within the normal range (Quetelet index between 19 and 26) expressed as weight (kg) / height (m2) .
- •Medical history , physical examination within normal appliances .
- •No evidence of significant organic or psychiatric disease based on history, physical examination and laboratory tests .
- •Laboratory tests (hematology and biochemistry) within the normal range , according to normal reference values of the Biochemistry laboratory of Hospital de la Santa Creu i Sant Pau. Variations may be allowed based on clinical judgment of the Centre d' Investigacio Medicament (CIM ) .
- •Vital signs: blood pressure (Systolic Blood Pressure (SBP) > 90 <140 mm Hg / Diastolic Blood Pressure (DBP) > 50 <90 mm Hg ), heart rate (> 50 <90 ) , temperature and ECG record within normal range.
- •Not having participated in another clinical trial during the previous three months at the beginning of the current study .
- •Not having donated blood in the previous four weeks.
- •Free acceptance to participate in the trial. Written informed consent signed.
- •Use of effective contraception different from oral contraceptives.
排除标准
- •Previous history of alcohol or drug use or abuse during the previous month to the selection process.
- •High consumption of stimulant beverages (> 5 coffee, tea, cola drinks daily).
- •Previous history of allergy, drug hypersensitivity or idiosyncrasy.
- •Taking any medication in the 4 weeks preceding the trial, including non-prescription medicines and herbal remedies.
- •Positive serology for hepatitis B, C or HIV.
- •History or clinical evidence of cardiovascular disease, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological or other chronic diseases.
- •Having had surgery during the previous 6 months.
- •Having donated blood in the month before the study began.
- •Positive pregnancy test at any monitoring during the study.
研究组 & 干预措施
Nifedipine oral solution
Nifedipine 5 mg/mL oral solution, 6 mL (30 mg of Nifedipine) at single dose
干预措施: Nifedipine oral solution (Drug)
Nifedipine soft gelatine capsules
Nifedipine soft gelatine capsules x3 (total 30 mg Nifedipine) at a single dose
干预措施: Nifedipine soft gelatine capsules (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve (AUC 0-24h)
时间窗: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
Maximal plasmatic concentrations, Cmax
时间窗: pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose
次要结局
- Time to maximal plasmatic concentrations, Tmax(pre-dose and +10', +20', +30', +45', +1h, +1h15', +1h30', +2h, +3h, +5h, +7h, +9h, +12h y +24h post dose)