Multiple-dose tolerability and effect of food

Completed

• Conditions: Safety / pharmacokinetics of Dulamin; Not Applicable

• Registration Number: ISRCTN64029954
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Age 18-45 years
2. Caucasian
3. Informed consent
3. Healthy men and women
4. Body mass index between 18 and 29 kg/m2

Exclusion Criteria

1. More than moderate smoker
2. Demonstrating excess in xanthine consumption
3. More than moderate alcohol consumption
4. Any history of alcohol or drug abuse
5. Demonstrating any active physical disease, acute or chronic
6. History or any current evidence of clinically relevant allergies or idiosyncrasies to drugs or food
7. History (within the last 2 years) of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as current hay fever 8. Proneness to orthostatic dysregulation, fainting, or blackouts
9. ECG abnormalities of clinical relevance
10. History (within the last 2 years) of chronic gastritis or peptic ulcers
11. History (within the last 2 years) of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological (especially history of epileptic seizures), endocrine, immunological, psychiatric or cardiovascular diseases, myopathies, or bleeding tendency
12. History (within the last 2 years) of malignancy
13. Pregnant or nursing women
14. Women of childbearing potential who are not using a highly-effective method of birth control
15. Laboratory values outside the reference range that are of clinical relevance
16. Positive test for human immunodeficiency virus (HIV) antibodies and antigens
17. Positive Hepatitis B-virus surface antigen (HBsAg) test
18. Positive Anti-hepatitis C-virus antibodies (Anti-HCV) test
19. Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis abuse
20. Ethanol consumption within 48 h before administration of IMP
21. Consumption of xanthine-containing food or beverages within 48 h before administration of IMP
22. Any gastrointestinal complaints within 7 days before first administration of IMP
23. Use of any medication within 4 weeks before first administration of IMP

Study & Design

• Study Type: Interventional
• Study Design: Not specified