A Phase 1 interventional study of Xanthine Oxidase Inhibitor and nonsteroidal anti-inflammatory drug in Gout and Hyperuricemia, sponsored by LG Chem. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-26.
Sponsored by LG Chem · Phase 1, Interventional, and Treatment
This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in combination in healthy subjects.
215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.
This study's enrollment of 24 is below the median of 64 across 172 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Period 1: LC350189 200mg (QD) Day 1\~ Day 4, Period 2: Naproxen 500 mg (BID) Day 8 \~ Day 12 , Period 3 : LC350189 200mg (QD) + Naproxen 500 mg (BID) Day 13\~19
Drug: Xanthine Oxidase Inhibitor · Drug: nonsteroidal anti-inflammatory drug
LC350189 200mg qd
Also known as: LC350189
Naproxen 500mg BID
Also known as: Naproxen
Maximun observed concentration (Cmax) of LC350189 and Naproxen from plasma
Pharmacokinetic
Time frame: From baseline up to Day 18
Area under the concentration-time curve (AUC) of LC350189 and Naproxen from plasma
Pharmacokinetic
Time frame: From baseline up to Day 18
Apparent terminal half-life (t1/2) of LC350189 and Naproxen from plasma
Pharmacokinetic
Time frame: From baseline up to Day 18
Incidence of Adverse events
Safety
Time frame: From baseline up to Day 18
Changes in concentration of uric acid in plasma by uricase method
Pharmacodynamic
Time frame: From baseline up to Day 17
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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LG Chem