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Binding interaction of polystyrene sulfonate and amitriptyline

Assessing the binding interaction of polystyrene sulfonate with amitriptyline in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26934
Enrollment
9
Registered
2020-04-17
Start date
2020-08-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

drug-drug interaction chronic renal failure depression neuropathic pain

Interventions

Intake of amitriptyline alone and amitriptyline with polysytrene sulfonate

Sponsors

Deventer Ziekenhuis
Lead Sponsor

Eligibility

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

MeasureTime frame
To determine whether polystyrene sulfonate has an effect on exposure of amitriptyline, when taken simultaneously, compared to amitriptyline taken alone in healthy volunteers, expressed in Cmax and AUC0-8h.

Contacts

Public ContactIlona Prins-Can

Deventer ziekenhuis

i.prins-can@dz.nl0570536242

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)