Abstract | PURPOSE: METHODS: We performed a prospective cross-over study in nine healthy volunteers. Participants were 18 years of age or older, did not use any medication, and had no known allergy to amitriptyline or polystyrene sulfonate. Participants visited Deventer Teaching Hospital twice. Once they received a single dose of amitriptyline 50 mg and once they received a single dose of both polystyrene sulfonate 15 g and amitriptyline 50 mg taken concomitantly, with a wash out period of at least 1 week. After intake of the medication, six blood samples were collected, at 2, 3, 4, 5, 6, and 8 h. Blood samples were analysed to determine maximum concentration (Cmax) and area under the curve 0-8 h after intake (AUC0-8 h). Difference in Cmax and AUC0-8 h was analysed with a paired T-test or Wilcoxon signed rank test, depending on normality of the data. A p-value < 0.05 was considered statistically significant. RESULTS: Of the nine participants included, eight participants completed both visits to the hospital. Mean maximum concentration (Cmax) of amitriptyline was 35.61 µg l-1 (95% CI 27.90-43.33 µg l-1) when taken alone, compared to 9.25 µg l-1 (95% CI 6.59-11.92 µg l-1) when taken with polystyrene sulfonate (p < 0.001). Mean AUC0-8 h of amitriptyline was 168.20 µg × h l-1 (95% CI 139.95-196.45 µg × h l-1) when taken alone and 45.78 µg × h l-1 (95% CI 30.20-61.36 µg × h l-1) when taken with polystyrene sulfonate (p < 0.0001). CONCLUSION: TRIAL REGISTRATION: NL8539 (17 April 2020).
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Authors | I Prins-Can, I R F van Berlo-van de Laar, M Zeeman, C G Vermeij, E van 't Riet, K Taxis, F G A Jansman |
Journal | European journal of clinical pharmacology
(Eur J Clin Pharmacol)
Vol. 78
Issue 5
Pg. 839-845
(May 2022)
ISSN: 1432-1041 [Electronic] Germany |
PMID | 35171315
(Publication Type: Journal Article)
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Copyright | © 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. |
Chemical References |
- Polystyrenes
- Amitriptyline
- polystyrene sulfonic acid
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Topics |
- Adolescent
- Adult
- Amitriptyline
(pharmacology)
- Area Under Curve
- Cross-Over Studies
- Healthy Volunteers
- Humans
- Polystyrenes
- Prospective Studies
- Renal Insufficiency, Chronic
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