ISRCTN46595731已完成1 期
Bioequivalence study of a new ibuprofen arginine 600 mg tablet formulation versus ibuprofen arginine 600 mg sachet in healthy volunteers
Zambon (Italy)0 个研究点目标入组 24 人开始时间: 2023年10月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Informed consent: subjects able to complete and sign the informed consent before inclusion in the study
- •2. Sex and age: men and women, 18-55 years old inclusive
- •3. Body Mass Index: 18.5-30 kg/m² inclusive
- •4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 60-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
- •5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Investigator and to comply with the requirements of the entire study
- •6. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception:
- •6.1. Hormonal oral, implantable, transdermal or injectable contraceptives for at least 2 months before the screening visit
- •6.2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
- •6.3. A male sexual partner who agrees to use a male condom with spermicide
- •6.4. A sterile sexual partner
- •Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted.
- •For all women, pregnancy test results must be negative at screening and Day -1.
排除标准
- •1. Subjects: subjects younger than 18 years or older than 55 years, subjects unable to give informed consent, subjects with cognitive impairment and otherwise non-healthy subjects
- •2. SARS-CoV-2 test: positive on COVID-19 Antigen Rapid Test at screening or Day -1
- •3. Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities
- •4. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- •5. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- •6. Allergy: ascertained or presumptive hypersensitivity to the active principle or formulations' ingredients or both; history of anaphylaxis to drugs or allergic reactions in general (in particular to NSAIDs), which the Investigator considers may affect the outcome of the study
- •7. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, immunological or neurological diseases that may interfere with the aim of the study
- •8. Medications: medications, including over-the-counter (OTC) medications, herbal remedies and vitamins, for 2 weeks before the start of the study. Hormonal contraceptives for women will be allowed
- •9. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
- •10. Blood donation: blood donations for 3 months before this study
- •11. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025], caffeine (>5 cups coffee/tea/day) or tobacco abuse (>10 cigarettes/day)
- •12. Drug test: positive result at the drug test at screening or Day -1
- •13. Alcohol test: positive alcohol test on Day -1
- •14. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- •15. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women.
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