Healthy Subjects Clinical Trial
Official title:
An Open-label, Parallel Group, Randomized, Two-sequence, Three-way Crossover Study to Assess the Relative Bioavailability of Solifenacin Succinate and Mirabegron Fixed-dose Combination Tablets Compared to Co-administration of Single Entity Tablets at Three Dose Strengths in Healthy Male and Female Subjects
This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths.
There are three parallel groups each with 24 healthy male and female subjects (with a
minimum of 10 subjects per gender). Each group receives one dose strength.
The study utilizes a partial replicate cross-over design with three periods and each subject
receives the same strength of either the FDC or SET formulation twice.
Screening takes place within 21 days before admission and subjects are admitted on Day -1.
Dosing takes place on Day 1, after an overnight fast of at least 10 hours. Subjects remain
fasted until 4 hours post-dose. There is a wash-out period of at least 14 days between each
dose administration.
Subjects are discharged on Day 4 and return to the clinical unit on Days 5, 6, 7, 9 and 11
for outpatient assessments.
An End-of-Study Visit (ESV) takes place on Day 11 of Period 3 or within 7-14 days after
discontinuation.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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