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

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

Official Title
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A Randomised, Double-blind, Double-dummy, Placebo-controlled Cross-over Trial to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets (120 mg Valerian / 80 mg Lemon Balm)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Songha® Night
* Drug: Oxazepam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Songha® Night<br> | Drug: Songha® Night<br> <br> |
| Active Comparator: Placebo + Oxazepam<br> | Drug: Oxazepam<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test |  | 08:00h, 09:30h, 11:00h at Day 7 of each treament period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Pupillary Unrest Index (PUI) measured by pupillographic sleepiness test |  | up to day 36 | 
| Change in subjective sleepiness rated on a 7 point scale | Stanford Sleepiness Scale | up to day 36 | 
| Change in subjective sleepiness measured on a visual analogue scale (VAS) |  | up to day 36 | 
| Change in sleep quality measured on a visual analogue scale (VAS) |  | up to day 36 | 
| Global Assessment of tolerability by investigator on 4-point scale |  | Day 36 | 
| Global Assessment of tolerability by patient on 4-point scale |  | Day 36 | 
| Number of subjects with adverse events |  | up to 36 days |