DRKS00020899已完成1 期
Bioequivalence study of two oral fixed-dose combination tablets of 250 mg acetylsalicylic acid, 250 mg paracetamol and 65 mg caffeine in healthy volunteers after controlled fasting - P360
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
Pharmacokinetics Bioequivalence of P360-tablets and Excedrin® film-coated tablets was demonstrated under fasting conditions for ASA, Paracetamol and Caffeine in healthy male and female subjects. Geometric mean ratios for AUC0-t, AUC0-inf and Cmax of all analytes were close to 100% with the 90% confidence intervals fully within the acceptance intervals (80.00%-125.00%). Safety Single oral doses of P360-tablets or Excedrin® were well tolerated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Main inclusion criteria:
- •1. The subject is healthy as determined by their medical history, a physical examination including vital signs, an electrocardiogram (ECG) and clinical laboratory testing.
- •2. The subject is male or female and 18 to 55 years of age inclusive, at the time of signing the informed consent.
- •3. The subject is able to read, write and fully understand German.
- •4. The subject has a body mass index (BMI) within the range of 18.5 to 30.0 kg/m2 (inclusive).
- •5. The subject is a non-smoker since at least 6 months as confirmed by an interview and a cotinine test at screening and on Day -2 of each period.
- •6. A male subject who is not vasectomized with a partner of childbearing potential must agree to refrain from fathering a child during the study and must agree to use effective contraception consisting of a combination of 2 forms of birth control (1 of which must be a barrier method) as detailed below in inclusion criterion 7, 2 days before the first dose of study medication (as appropriate), until the end of the study and refrain from donating sperm during this period.
- •7. A female subject is eligible if she is not pregnant (negative beta human chorionic gonadotropin [beta-hCG] test at screening and a negative urine pregnancy test on Day -2 in each period) and not breastfeeding.
- •8. The subject provided written informed consent prior to any clinical study-specific procedures.
排除标准
- •1. Any history or evidence of any clinically significant cardiovascular, gastrointestinal endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the investigator.
- •2. Any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •3. Known hypersensitivity to ASA, paracetamol, caffeine or to any of the other excipients.
- •4. Known hypersensitivity to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs), which have been manifested as asthma, urticaria, nasal polyps, angioedema and other allergic reactions.
- •5. History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (2 or more distinct episodes of proven ulceration or bleeding).
- •6. Difficulty in swallowing.
- •7. History or evidence of malabsorption or any gastrointestinal surgery except appendectomy and herniotomy.
- •8. History of any chronic disease which might interfere with the absorption, distribution, metabolism or excretion of the investigational medicinal product (IMP).
- •9. Known disorders with increased bleeding risk (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer), known coagulation disorders (e.g. von Willebrand´s disease, hemophilia) or known sensitivity to common causes of bleeding (e.g. nasal).
- •10. Febrile illness within 1 week before the first study drug administration.
- •11. Previous medical history of gout or reduced uric acid excretion.
- •12. Recently had (past 30 days) or plans to have surgery, an invasive procedure, tattoos or piercings during the trial or 2 weeks after treatment.
- •13. Any clinically significant laboratory findings that, in the opinion of the Investigator, would preclude inclusion in the trial; creatinine and/or liver function tests (alanine aminotransferase, aspartate aminotransferase) or total bilirubin above 1.2 x upper limit of normal (ULN) confirmed by two repeated measurements, when checked at screening.
- •14. Any clinically significant abnormality following the investigator’s review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or admission to the clinical unit.
- •15. Subjects with abnormal ECG parameters (after at least 5 minutes rest in supine position): heart rate <45 and >90 bpm, PQ interval >220 milliseconds (ms), QRS duration >120 ms, QTcF interval >450 ms at screening visit.
- •16. Supine systolic blood pressure (after at least 5 minutes rest in supine position) > 140 mmHg or < 100 mmHg or diastolic blood pressure > 90 mmHg or < 50 mmHg and pulse rate < 45 or > 90 beats per minute (at screening).
- •17. Positive alcohol or drug screen at Screening or on Day -2 of each dosing period.
- •18. Positive cotinine test at screening and on Day -2 of each period
- •19. Use of any prescribed or non-prescribed drugs (including vitamins or hormone replacement therapy, natural and herbal remedies, e.g., St. John’s Wort) in the 2 weeks or 5 half-lives, whichever is longer, prior to the first study drug administration. Oral, injectable or topical contraceptives are permitted as they are acceptable methods of contraception.
- •20. Intake of ASA or paracetamol or other NSAID containing these products within 2 days prior to the first study dr
研究者
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