ISRCTN64029954
Completed
N/A
A phase I study to assess the safety and tolerability of repeated oral doses of 1200 mg and 2400 mg Dulamin once daily for 2 weeks in healthy volunteers as well as to evaluate the relative bioavailability of film-coated tablets containing 1200 mg Dulamin and to evaluate effects of food on its pharmacokinetics
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 sites36 target enrollmentFebruary 18, 2013
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG (Germany)
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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