Assessing the binding interaction of polystyrene sulfonate with amitriptyline in healthy volunteers;The BIND-study
Phase 4
Completed
- Conditions
- betreft interactiestudie in gezonde vrijwilligers.drug-drug interaction study
- Registration Number
- NL-OMON49827
- Lead Sponsor
- Deventer Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
- The participant is at least 18 years of age
Exclusion Criteria
- Known allergy to one of the investigated substances
- Known renal or hepatic impairment
- Pregnancy
- Breast feeding
- Use of other medication within 24 hours of the study period (oral
contraceptives within 12 hours of the study period)
- Contra-indication for one of the investigated substances (such as recent
myocardial infarction, cardiac arrhythmias, hypokalaemia and obstructive bowl
disease)
- History of a gastro-intestinal condition that may interfere with absorption
of amitriptyline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in exposure of amitriptyline in the presence and absence of<br /><br>polystyrene sulfonate, expressed in Cmax and AUC0-8h.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>