Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/19/2019 |
| Start Date: | October 4, 2018 |
| End Date: | January 6, 2019 |
A Phase I, Open-label, Randomized, 4-period Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of K-285 Compared With a Single Oral Dose of Indomethacin Capsule in Healthy Adult Volunteers
This study is to compare the PK parameters of multiple doses and applications of K-285 with a
single dose of indomethacin capsule.
single dose of indomethacin capsule.
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 exclusion criteria outlined in the clinical study protocol.
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