Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Songha® Night; Drug: Placebo; Drug: Oxazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02273453

582.2

Details and patient eligibility

About

Study to determine the presence of a hang-over effect in healthy volunteers the day after the administration of Songha® Night

Enrollment: 54 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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54 participants in 3 patient groups, including a placebo group

Songha® Night

Experimental group

Treatment:

Drug: Songha® Night

Placebo + Oxazepam

Active Comparator group

Treatment:

Drug: Placebo

Drug: Oxazepam

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo