Multiple-dose tolerability and effect of food

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64029954

Enrollment

Registered

2013-02-18

Start date

2013-02-05

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety / pharmacokinetics of Dulamin Not Applicable

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 Da

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

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Plasma pharmacokinetics	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026