Last updated: 11/04/2018 13:05:57
A Dose-Ranging Study to Evaluate the Pharmacokinetics and Pharmacodynamics of a Sleep Aid
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Dose-Ranging Study to Evaluate the Pharmacokinetics and Pharmacodynamics of a Sleep Aid
Trial description: This initial dose-ranging Pharmacokinetic (PK) study is designed to identify the most appropriate doses of the test product to use to confirm efficacy in sleep induction.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
PK profiles and estimate parameters
Timeframe: change from baseline to 24 hours post dose
Secondary outcomes:
CDR testing of psychomotor function
Timeframe: change from baseline to 24 hours post dose
Karolinska Sleepiness Scale
Timeframe: change from baseline to 3 hours post dose
Interventions:
Drug: Doxylamine Succinate
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
2010-14-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sleep Disorders
Product
doxylamine succinate
Collaborators
Not applicable
Study date(s)
December 2010 to December 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 Year
Accepts healthy volunteers
none
- Self-reported history of chronic intermittent difficulty with sleep at night, 2-5 nights a week, at least 1 week a month for the last 3 months.
- Willingness to forego caffeine-containing products while confined to the study site (12 days).
- Subjects with a history of glaucoma.
- Subjects with a history of breathing problems, such as asthma, emphysema, or chronic bronchitis.
Inclusion and exclusion criteria
Inclusion criteria:
- Self-reported history of chronic intermittent difficulty with sleep at night, 2-5 nights a week, at least 1 week a month for the last 3 months.
- Willingness to forego caffeine-containing products while confined to the study site (12 days).
Exclusion criteria:
- Subjects with a history of glaucoma.
- Subjects with a history of breathing problems, such as asthma, emphysema, or chronic bronchitis.
- Men who have a history of difficulty urinating due to an enlarged prostate gland.
- Subjects who have a history of diabetes.
- Subjects with reversed or shifting wake/sleep cycle.
- Subject has donated blood or experienced significant blood loss within 56 days of Baseline visit, donated plasma within 7 days of Baseline visit, or has a hemoglobin value of <12.0 g/dl.
- Subject has known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Users of nicotine-containing products, including tobacco products and nicotine replacement therapies.
- Has used any prescription medication within 30 days prior to dosing with the exception of lipid lowering drugs, antihypertensive medications, and oral contraceptives provided they have been stable on treatment for at least 1 month prior to study entry.
- Has used any herbal or nutritional supplements (except vitamins and minerals) within 7 days prior to the first study session.
- Has used any OTC medication, including herbal supplements, within 48 hours prior to the first study session.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2010-14-12
Actual study completion date
2010-14-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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