Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Clinical pharmacology
Age
18–45
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
The informed consent form must be signed before any study specific tests or procedures are done
Confirmation of the subject's health insurance coverage prior to the first screening visit
Healthy male subject
Ethnicity: Caucasian
Age: 18 to 45 years (inclusive) at the first screening visit
Body mass index (BMI) above or equal 18, and below or equal 29.9 kg / m²
Ability to understand and follow study-related instructions
You may not be if
Suspicion of drug or alcohol abuse
Regular daily consumption of more than 1 L of xanthin-containing beverages
Intake of foods or beverages containing grapefruit within 2 weeks prior to the first study drug administration (the same applies to pomelos and St. John's Wort)
Use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. CYP3A inhibitors or CYP3A inducers)
* examples for CYP3A inhibitors: erythromycin, inhibitors of human HIV protease (e.g. ritonavir, saquinavir), amiodarone, diltiazem, verapamil, fluconazole, itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodon, cimetidine;
* examples for CYP3A inducers: rifampicin, carbamazepin, phenytoin, phenobarbital, or products containing St. John's Wort;
Systolic blood pressure below 116 or above 145 mmHg (after at least 15 min supine)
At the first screening visit
* Diastolic blood pressure above 95 mmHg (after at least 15 min supine)
* Heart rate below 45 or above 95 beats / min (after at least 15 min supine) at the first screening visit
* Clinically relevant findings in the physical examination
* Positive urine drug screening or alcohol breath test
Exclusion periods from other studies or simultaneous participation in other clinical studies
Clareo Health | Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed
