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

NCT ID: NCT02273453

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Songha® Night

Group Type: EXPERIMENTAL

Songha® Night

Intervention Type: DRUG

Placebo + Oxazepam

Group Type: ACTIVE_COMPARATOR

Oxazepam

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Songha® Night

Intervention Type: DRUG

Oxazepam

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

582.2

Identifier Type: -

Identifier Source: org_study_id