Assessing the binding interaction of polystyrene sulfonate with amitriptyline in healthy volunteers;The BIND-study

Assessing the binding interaction of polystyrene sulfonate with amitriptyline in healthy volunteers;The BIND-study - BIND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49827

Enrollment

Registered

2020-04-23

Start date

2020-08-31

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

betreft interactiestudie in gezonde vrijwilligers. drug-drug interaction study

Interventions

Healthy volunteers will receive a single dose of amitriptyline 50mg twice. Once simultaneously with polystyrene sulfonate 15grams and once without polystyrene sulfonate. There will be a wash out per

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - The participant is at least 18 years of age

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Difference in exposure of amitriptyline in the presence and absence of polystyrene sulfonate, expressed in Cmax and AUC0-8h.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)