| Autor: |
BIERNAT, PAWEŁ, BALWIERZ, RADOSŁAW, MELER, JAN, MICEWICZ, EWA, DYLIŃSKI, MIESZKO, BURSY, DAWID, GUZIEWICZ, MAŁGORZATA, URBAN-STOJANOWSKA, KATARZYNA |
| Předmět: |
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| Zdroj: |
Medical Science Pulse; 2024 Supplement, Vol. 18, p85-85, 1p |
| Abstrakt: |
Introduction: Transdermal drug delivery systems for the management of diabetes are a promising approach to provide better clinical outcomes compared to conventional dosage forms. The prolonged and sustained release profile of the drug will provide better glucose control and better prediction of the glucose profile. The use of an extendedrelease transdermal system in the treatment of type 2 diabetes offers the possibility of increasing patient comfort and reducing side effects, e.g., from the gastrointestinal tract, resulting from the often-observed polypragmasy. Aim: The primary objective of the phase 1 clinical study was to evaluate the safety, relative bioavailability and pharmacodynamic effect of a newly developed Dapagliflozin Transdermal System TTS MTC-D, after administration in healthy volunteers. Material and methods: The study was randomized, crossover, open label, 2-way, 2-period, one center, single dose of TTS compared to daily oral dosing of reference treatment in healthy subjects. Subjects were randomized to either wear TTS MTC-D for 7 days or to receive once a day dapagliflozin film-coated tablets - Forxiga for 7 days under fasting conditions in study period 1. The treatment was switched for subjects in period 2. A wash-out time between study periods was 7 days. During dosing blood and urine samples for PK were collected and the safety evaluation were performed. Results: The pharmacokinetic profiles of the study product and the reference product were confirmed to be consistent. Statistical analysis showed that the mean efficiency of the TTS system expressed by the ExTRA value was 0.94 (94%) and statistically existed higher than that calculated for Forxiga tablets - 0.68 (68%). Conclusions: After transdermal administration of the TTS MTC-D developed by BIOTTS, dapagliflozin penetrates the skin barriers and enters the bloodstream. Good safety and tolerability of the study product was found, with only mild to moderate adverse events. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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