Status:
COMPLETED
Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
20-60 years
Phase:
PHASE1
Brief Summary
Study to determine the presence of a hang-over effect in healthy volunteers the day after the administration of Songha® Night
Eligibility Criteria
Inclusion
- Healthy male or female Caucasian subjects aged 20-60 years
- Normal outcome in Pittsburgh Sleep Quality Index (PSQI), below mean +2 Standard Deviation (SDs)
- No manifest sleep disorder diagnosed by polysomnography
- Normal pupillary function
- Willing and able to give written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to participation in the study and able to perform the study during the full time period of 36 days
Exclusion
- Subjective sleep duration of less than 3 hours in the night before the test
- Caffeine, nicotine or alcohol on the day (from midnight) of the test
- Alcohol consumption on the evening before visits 3, 5 or 7
- Eye-drops or other drugs, taken orally or intravenously, influencing pupil size or motility
- Shift work
- Drug and alcohol abuse
- Use of psycho-active drugs during the past 30 days
- Any treatment that might interfere with the evaluation of the test drug
- Any drug known to interact with benzodiazepines and related drugs, e.g. antiepileptics, antihistaminics, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome P450
- Any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
- Known hypersensitivity to any of the ingredients of the study drugs
- Pregnant or nursing women or inadequate birth control methods (this applies to female of childbearing potential only)
- Participation in another trial within the past 30 days
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02273453
Start Date
February 1 2003
Last Update
October 24 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.