Healthy male and female volunteers
Conditions
Interventions
Trade Name: Beloc Zok 95 mg
Product Name: Beloc Zok
Product Code: 48563.02.00
Pharmaceutical Form: Tablet
CAS Number: 98418-47-4
Other descriptive name: Metoprolol-Succinat
Trade Name: Carvedilol 25
Sponsors
University of Göttingen; Dep. of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All male and female healthy volunteers aged between 18 and 50 years with normal body weight are eligible for this study. The required pre-conditions in detail: -Age: 18-50 years -Caucasian (German origin), African or Asian -Bodyweight 50 – 100 kg and BMI 18 – 25 kg/m² -Non smokers and ex smokers with abstinence >2 month -Willingness to meet the study instructions and to co-operate with the study personal -Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Volunteers taking any medication before or during the trial are excluded from the study. Taking oral contraceptive drugs is also an exclusion criterion. Exclusion criteria in detail are: -Age 50 years -Known pregnancy or lactation period -Any significant abnormality in the ECG, any known or hint on any cardiac disease including any abnormality in auscultation except of the abnormality is judged clinically insignificant by a cardiologist -Significant abnormalities as result of the medical-screening-laboratory-analysis, especially of the liver and kidney related parameters. -Any disease affecting liver or kidney or impairment of the liver or kidney-function -Asthma -Known Raynod’s syndrome -Any major acute disease or fever (Temp. > 37,5 °C). -Any major gastrointestinal disease and any gastrointestinal disorder that is expected to significantly interfere with the pharmacokinetics of the study drug -Gastrointestinal surgery (except appendectomy or herniotomy) -Participation in any other clinical study or donation of blood within 4 weeks before the start of this study -Current smokers or having ever smoked more than 1 pack year -Taking any medication before or during the trial including oral contraceptive drugs -Alcohol and drug addiction or any abusive use of medicaments -Any other findings that could compromise the safety of the participant or the quality of the study-results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Treatment with the beta-blockers metoprolol and Carvedilol is a field of medicine in which significant further improvement in therapeutic outcome can be expected by the application of pharmacogenetics based drug dosage. A lot of observational study data supports the hypothesis that both, dosage regimens at initiation of treatment and maintenance dosage, should be modified according to the CYP2D6 genotype to achieve optimal drug effects in all patients while minimizing adverse effects. To achieve this aim, the development of precise and actionable guidelines how to use the CYP2D6 genotype (e.g. measured by the Roche CYP2D6/2C19 array) is a first most important prerequisite. This will be developed for all major CYP2D6 genotypes based on hepatic clearance of metoprolol as the most specific clinical pharmacokinetic parameter and based on resting and exercise heart rate reduction as valid surrogate parameters of metoprolol and carvedilol clinical effects.;Secondary Objective: See above (Main objectives);Primary end point(s): Primary parameter for the development of dosage guidelines will be hepatic metoprolol clearance (total clearance minus renal clearance). The most important secondary parameter will be the maximum resting and exercise heart rate reduction due to metoprolol. Other kinetic and dynamic parameters and adverse events will be documented as well. | — |
Countries
Germany
Outcome results
None listed