Effects of Ginkgo biloba extract on blood levels of the drug rivaroxaban and on blood clotting
- Conditions
- Pharmacokinetics and pharmacodynamics of rivaroxabanNot Applicable
- Registration Number
- ISRCTN41838730
- Lead Sponsor
- Dr. W. Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
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
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.
Note:
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method