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21 March 2013
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| [ Print-friendly version ] |
| Multiple-dose tolerability and effect of food |
| ISRCTN | ISRCTN64029954 |
| DOI | 10.1186/ISRCTN64029954 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Multiple-dose tolerability and effect of food |
| Scientific title | 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 |
| Acronym | N/A |
| Serial number at source | 561501.01.002 |
| Study hypothesis | The aim of this study is to evaluate the safety and tolerability of repeated oral doses of 1200 and 2400 mg Dulamin in healthy subjects as well as to evaluate the bioavailability and the effect of food on pharmacokinetics. |
| Lay summary |
Background and study aims
Dulamin is an alcoholic extract of Filipendula ulmaria. The objective of the study is to obtain information on the safety, tolerability, and pharmacokinetics of repeated oral doses of Dulamin in healthy subjects as well as information on the bioavailability and effects of food on pharmacokinetics. Who can participate? Adult healthy Caucasian males and females (aged 18 – 45 years) can participate in the study. What does the study involve? One group of the patients will receive Dulamin once and for 15 days in two cohorts of 1200 mg daily dose and 2400 mg daily dose. Safety assessments are performed during the whole study and blood sampling will be made at the specified time points after the first dose and after the last dose of Dulamin for 48 hours. In another group, single doses of 1200 mg Dulamin will be investigated on three occasions: once as tablets with no meal, once as drinking suspension with no meal, once as tablets after administration of a meal. What are the possible benefits and risks of participating? The participants are healthy people and there will be no direct benefits in participating. Filipendula ulmaria is a traditional herbal medicine in Europe. According to the ‘German monograph’, treatment with Filipendula ulmaria holds no risk of adverse drug reactions. Where is the study run from? The study will be performed in a specialised phase 1 unit in Germany. When is the study starting and how long is it expected to run for? The study will start in February 2013 and will run for about 6 months. Who is funding the study? Dr. Willmar Schwabe GmbH & Co. KG, Germany Who is the main contact? Dr. Stephan Klement Stephan.klement@schwabe.de |
| Ethics approval | Ethics Commission of the State Medical Association of Baden-Württemberg [Ethik-Kommissin der Landesärztekammer Baden -Württemberg], 16 October 2012 |
| Study design | Single-centre randomized placebo-controlled double-blind dose-ascending study with an open-label 3-period 3-way cross-over part |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Safety / pharmacokinetics of Dulamin |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 05/02/2013 |
| Anticipated end date | 30/06/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet. |
| Target number of participants | 36 |
| Interventions |
One single day and 15 days in the multiple ascending dose part of the study; Three single doses separated by a washout of at least 1 week in the food effect/bioavailability part of the study.
Multiple dosing part Cohort 1= 1200mg. Single dose of 2 tablets 600 mg Dulamin on Day 1, followed by intake of 2 tablets 600 mg Dulamin once daily from day 3 – day 17 Cohort 2= 2400mg. Single dose of 4 tablets 600 mg Dulamin on Day 1, followed by intake of 4 tablets 600 mg Dulamin once daily from day 3 – day 17. Blood sampling PK: at predose and at 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, and 48 h after administration on Days 1 and 17; Days 15 and 16: predose ECG: at predose and on Day 17 at predose, and at 1, 2, 4, 8, 12, 24, and 48 h after administration. Bioavailability and effects of food part Cohort 3= 1200mg. Single dose of 2 tablets 600 mg Dulamin two times and once 1200 mg drinking suspension of extract; intake times separated by a wash out of at least one week Blood sampling PK: at predose and at 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, and 48 h after administration ECG: at predose and 24 and 48 h after administration |
| Primary outcome measure(s) |
1. Adverse events
2. Laboratory data 3. Blood pressure 4. Pulse rate 5. Electrocardiogram (ECG) Adverse events, ECG and vital signs daily, Laboratory values: at screening visit, pre-dose, day 3, day 10, day 17, day 19, follow up visit. |
| Secondary outcome measure(s) | Plasma pharmacokinetics |
| Sources of funding | Dr. Willmar Schwabe GmbH & Co. KG (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Wolfgang Timmer |
| Address | Grenadierstraße 1 |
| City/town | Mannheim |
| Zip/Postcode | 68167 |
| Country | Germany |
| Sponsor | Dr. Willmar Schwabe GmbH & Co. KG (Germany) |
| Address | Willmar-Schwabe-Straße 4 |
| City/town | Karlsruhe |
| Zip/Postcode | 76227 |
| Country | Germany |
| Sponsor website: | http://www.schwabepharma.com/ |
| Date applied | 29/01/2013 |
| Last edited | 18/02/2013 |
| Date ISRCTN assigned | 18/02/2013 |
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