Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults

• Status: Completed
• Trial end date: 2019-01-06
• Target enrollment: 0
• Participant gender: All

Summary

This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kowa Research Institute, Inc.
• Treatments: Indomethacin

Criteria

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.