Stepwise ascending single-dose tolerability of Dulamin

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2011
INTERVENTION: Single doses of 150 mg, 300 mg, 600 mg, 1200 mg, 1800 mg and 2400 mg Dulamin or placebo CONDITION: Safety of Dulamin ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: 1. Adverse events; 2. Laboratory data; 3. Blood pressure ; 4. Pulse rate; 5. Electrocardiogram SECONDARY OUTCOME: Plasma pharmacokinetics 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
Epistemonikos ID: 2641d6494a7cc87c265297298738d9cbd611d314
First added on: Aug 22, 2024