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.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
betreft interactiestudie in gezonde vrijwilligers.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in exposure of amitriptyline in the presence and absence of
polystyrene sulfonate, expressed in Cmax and AUC0-8h.
Secondary outcome
not applicable
Background summary
The resin polystyrene sulfonate is often used for binding potassium for
prevention of hyperkalaemia. Because of their binding properties, resins could
potentially bind other medications before they can be absorbed completely and
thereby decrease their bioavailability. This is confirmed in in vitro binding
interaction studies. Our own in vitro research has shown a binding interaction
between polystyrene sulfonate and amitriptyline.
More information is needed on this possible binding interactions to use
amitriptyline and polystyrene sulfonate effectively and safely.
Study objective
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.
Study design
A prospective, cross-over trial in healthy volunteers
Intervention
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 period of at least one week.
Study burden and risks
The study involves healthy volunteers. The participants will visit the hospital
twice. Both times they will receive a single dose of amitriptyline and once
they will receive polystyrene sulfonate concomitantly. Six blood samples will
be collected at each visits. Both amitriptyline and polystyrene sulfonate are
all licensed products with a known mechanism of action and known side effects.
Because it involves a single dose of the substances, the risk is low.
Nico Bolkesteinlaan 75
Deventer 7416SE
NL
Nico Bolkesteinlaan 75
Deventer 7416SE
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-001569-36-NL |
| CCMO | NL73647.075.20 |