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NCT03712241
Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults
Phase 1 trial testing K-285 in Healthy in 15 participants. Completed in 6 January 2019.
6 January 2019
Quick facts
| Lead sponsor | Kowa Research Institute, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 15 |
| Start date | 4 October 2018 |
| Primary completion | 6 January 2019 |
| Estimated completion | 6 January 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- K-285 — full drug profile →
- Indomethacin (INDOMETHACIN) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Kowa Research Institute, Inc. — full company profile →
Who can join
Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03712241
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of K-285
Trials testing the same drug.
- NCT04484428 — A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle · Phase 2 · terminated
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Other Kowa Research Institute, Inc. trials
Trials by the same sponsor.
- NCT06525311 — A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis · Phase 1 · completed
- NCT05826353 — A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexi · Phase 3 · completed
- NCT05795699 — A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothel · Phase 3 · completed
- NCT05722262 — Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration · Phase 1 · completed
- NCT05327127 — Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03712241 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kowa Research Institute, Inc.
- Last refreshed: 17 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03712241.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing