Overactive Bladder Clinical Trial
Official title:
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects
This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.
This study will be a randomised, double-blind, placebo-controlled, dose-escalation, single
and multiple oral dose study conducted in 2 parts.
In Part A, each subject will participate in 1 treatment period only and reside at the
Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours
postdose), except for Group A4, where each subject will participate in 2 treatment periods
separated by a minimum of 13 days to evaluate the effect of food.
In Part B, each subject will participate in 1 treatment period only and reside at the CRU
from Day -1 (1 day before dosing) until the morning of Day 9 (48 hours after the final dose
on Day 7).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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