Healthy
Conditions
Brief summary
The primary objective of this trial was to investigate the potential effects of pentoxyverine on the ECGs of healthy subjects. A secondary objective was the exploration of safety and tolerability. Pharmacokinetics (PK) were only to be investigated if necessary for the explanation of ECG effects.
Interventions
DRUGpentoxyverine citrate
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) 12-lead ECG, clinical laboratory tests 2. Age ≥21 and ≤45 years 3. Body Mass Index (BMI) ≥18.5 and ≤29.9 kg/m² 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion criteria
1. Any finding of the medical examination (including BP, PR, and ECG) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. Surgery of the gastrointestinal tract (except appendectomy) 5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 6. History of relevant orthostatic hypotension, fainting spells or blackouts. 7. Chronic or relevant acute infections 8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 9. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial 10. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial 11. Participation in another trial with an investigational drug within two months prior to administration or during the trial 12. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) 13. Inability to refrain from smoking on trial days 14. Alcohol abuse (more than 60 g/day) 15. Drug abuse 16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial) 17. Excessive physical activities (within one week prior to administration or during the trial) 18. Any laboratory value outside the reference range that is of clinical relevance 19. Inability to comply with dietary regimen of trial site 20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms); 21. A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes from baseline in QTc interval | up to 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| number of adverse events | up to day 44 |
| Blood pressure change from baseline | up to day 44 |
| Pulse rate change from baseline | up to day 44 |
| assessment of global tolerability by 4-point scale | up to day 44 |
Outcome results
None listed