Healthy
Conditions
Brief summary
This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.
Interventions
DRUGK-285
Topical
DRUGIndomethacin
Capsule
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject provides written informed consent before any study specific evaluation is performed. * Subject is a healthy adult male or female aged 18 to 45 years, inclusive. * Subject has a BMI of 18 to 30 kg/m2, inclusive. * Subject meets all inclusion criteria outlined in the clinical study protocol.
Exclusion criteria
* Subject has abnormal findings or assessments that are clinically noteworthy at Screening or Admission (Day -1). * Subject has a supine blood pressure after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic at Screening or Admission (Day -1). * Subject has a supine heart rate after resting for 5 minutes that is outside the range of 40 to 100 beats per minute at Screening or Admission (Day -1). * Subject does not meet any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) | Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4 |
| Area under the plasma versus concentration time curve (AUC) | Day 2 to Day 7 of Periods 1, 2, and 3 and Day 1 of Period 4 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events | Through study completion approximately 33 to 38 days |
Countries
United States
Outcome results
None listed