NL-OMON51272
Completed
Not Applicable
Randomized, double-blind, placebo-controlled, 3-way cross-over study to characterize the pharmacodynamics and pharmacokinetics of single-dose intravenously administered biperiden in healthy elderly male and female subjects - Intravenous biperiden challenge in elderly subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cognitive impairment
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Elderly male or female subjects aged between 65 and 80 (inclusive) years old;
- •2\. Healthy subjects as defined by the absence of evidence of any clinically
- •relevant active or chronic disease following detailed medical and surgical
- •history review and a complete physical examination including vital signs,
- •12\-lead ECG, haematology, blood chemistry, and urinalysis;
- •5\. Absence of cognitive impairment evident by a score of 28 or higher on the
- •Mini Mental State Examination (MMSE);
Exclusion Criteria
- •1\. Clinically relevant history of abnormal physical or mental health
- •interfering with the study as determined from the medical history review and
- •the physical examinations obtained during the screening visit and/or at the
- •start of the first study day for each period as judged by the investigator
- •(including (but not limited to), neurological (including myasthenia gravis,
- •epilepsy and tardive dyskinesia), cardiovascular (including current
- •hypertension, orthostatic hypotension and recent myocardial infarction),
- •respiratory, gastrointestinal (including previous ileus or megacolon and past
- •or current gastro\-intestinal stenosis), hepatic, renal, urogenital (including
- •urinary retention or prostate hypertrophy) disorder or presence of narrow\-angle
Outcomes
Primary Outcomes
Not specified
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