ISRCTN41838730已完成1 期
A clinical trial to investigate the effects of Ginkgo biloba extract EGb 761® on the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy volunteers
Dr. W. Schwabe GmbH & Co. KG0 个研究点目标入组 42 人开始时间: 2020年11月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
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. Male and female volunteers
- •2. Age at least (=) 18 years at screening
- •3. Caucasian
- •4. Body mass index (BMI) 18.0 – 29.9 kg/m² (included)
- •5. Healthy on the basis of specified criteria evaluated at the screening visit (physical examination, ECG, vital signs, safety and coagulation laboratory)
- •6. Signed informed consent in accordance with the legal requirements
排除标准
- •1. Participation in a further clinical trial at the same time or within the past 3 months before screening
- •2. Female subjects: pregnancy or lactation
- •3. Female subjects of childbearing potential not using adequate contraception
- •4. Positive pregnancy test at screening or Day -1
- •5. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g., partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
- •6. Hypersensitivity to any of the IMPs or components thereof
- •7. Hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
- •8. Any condition which constitutes a contra-indication for treatment with EGb 761® (e.g., high bleeding risk, regular intake of coagulation-inhibiting drugs, epilepsy or history of seizures)
- •9. Any condition which constitutes a contra-indication for treatment with rivaroxaban (e.g., acute, relevant bleeding, lesions, clinical situations with increased risk of severe bleeding)
- •10. Presence of any possibly relevant active co-morbidity (including conditions that might affect absorption, distribution and elimination of the investigational compounds; acute or chronic infections)
- •11. Use of any concomitant medication within 2 weeks or less than 5× t½ of the respective medication before first administration
- •12. Presence of any possibly confounding clinical laboratory at screening including but not confined to abnormal values for complete blood count, coagulation, serology and clinical chemistry, if assessed as clinically relevant by the investigator.
- •As neither rivaroxaban nor EGb 761® are hepatotoxic, slight elevations are acceptable for hepatic parameters if there is no indication of apparent disease: 10% above upper limit of normal (ULN) for alanine aminotransferase (ALT), 20% above ULN for aspartate aminotransferase (AST) or bilirubin (except in case of Gilbert’s disease: elevated bilirubin is not relevant).
- •Slight elevation (10%) acceptable for renal parameters (except for creatinine) if there is no indication of apparent disease [Breithaupt-Grögler et al., 2017]
- •13. Depiction of bleeding tendencies defined by the presence of pathological coagulation parameters performed at screening, including but not confined to prothrombin time (Quick,), von Willebrand factor (vWF), platelet function assay PFA-100 and factor XIII
- •14. Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B-virus surface antigen (HBsAg), or anti-hepatitis C virus antibodies (anti-HCV) at screening
- •15. Positive immunological testing on occult blood in faeces at screening
- •16. Positive test for blood in urine at screening (except due to menses in female subjects)
- •17. Elevated blood pressure (confirmed by second measurement): Systolic blood pressure (SBP) = 140 mmHg or diastolic blood pressure (DBP) = 90 mmHg at screening
- •18. Pulse rate < 50 or > 90 bpm at rest at screening.
- •19. Relevant abnormality in 12-lead ECG at screening including, but not confined to prolonged HR-controlled QTc (normal ranges: QTcB = 450 ms [male s
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