Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults
NCT ID: NCT03712241
Last Updated: 2019-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2018-10-04
2019-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A
K-285 dose/application method A
K-285
Topical
Treatment B
K-285 dose/application method B
K-285
Topical
Treatment C
K-285 dose/application method C
K-285
Topical
Treatment D
Indomethacin capsule
Indomethacin
Capsule
Interventions
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K-285
Topical
Indomethacin
Capsule
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
45 Years
ALL
Yes
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Locations
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PPD Development, LP
Austin, Texas, United States
Countries
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Other Identifiers
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K-285-101
Identifier Type: -
Identifier Source: org_study_id
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