Safety of Dulamin Nutritional, Metabolic, Endocrine
Conditions
Interventions
Single doses of 150 mg, 300 mg, 600 mg, 1200 mg, 1800 mg and 2400 mg Dulamin or placebo
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age 18 - 55 years 2. Male 3. Caucasian 4. Informed consent 5. Healthy 6. Body mass index between 18 and 30 kg/m²
Exclusion criteria
Exclusion criteria: 1. History or current evidence of clinically relevant allergies 2. History or current evidence of any clinically relevant diseases suspected to influence PKs of the IMP or safety of the subjects: 2.1. Cardiovascular 2.2. Pulmonary 2.3. Hepatic 2.4. Renal 2.5. Gastrointestinal 2.6. Haematological 2.7. Endocrinological 2.8. Metabolic 2.9. Neurological 2.10. Psychiatric 3. History of malignancy 4. Febrile or infectious illness within 5 days prior to administration of IMP 5. Chronic or clinically relevant acute infections 6. Proneness to orthostatic dysregulation, fainting, or blackouts 7. Positive results in any of the virology tests for: 7.1. HIV I and II-antibody (Ab) 7.2. Hepatitis B surface antigen (HbsAg) 7.3. Anti-HBV capsid (Hbc) immune globulins (Ig) (IgG + IgM) 7.4. HCV-Ab 8. Positive illicit drug screen 9. Positive alcohol breath test 10. Clinically relevant history or current evidence for abuse of alcohol ( > 50 g/day ethanol) or drugs 11. Treatment with any agent known to induce/inhibit xenobiotic metabolising enzyme or transporter within 2 weeks prior to or during the study 12. Use of any medication (incl. over-the-counter medication) within 2 weeks before study drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment period 13. Consumption of any enzyme inducing or inhibiting aliments and beverages (e.g. broccoli, brussel sprout, grapefruit, grapefruit juice, St. John's Wort, star fruit etc.) within 72 hours prior to the start of the study 14. Consumption of any caffeine- or methylxanthine-containing product within 48 hours prior to the administration of IMP 15. Consumption of any flavonoid-containing product within 72 hours prior to the administration of IMP 16. Subjects with diseases or surgery of the gastrointestinal tract, which may interfere with drug absorption 17. Participation in drug studies within the last 30 days before administration of the IMP in the present study 18. Blood donation within the last 30 days before start of the study 19. Lack of ability or willingness to give informed consent 20. Vulnerable subjects (e.g. persons kept in detention)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse events 2. Laboratory data 3. Blood pressure 4. Pulse rate 5. Electrocardiogram | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetics | — |
Countries
Germany
Outcome results
None listed