NCT04886050

Relative Bioavailability Study to Assess an LC350189 Tablet Compared to an LC350189 Capsule in Healthy Adults

A Phase 1, Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Bioavailability of an LC350189 Tablet Relative to an LC350189 Capsule in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, crossover, single dose study. Two single doses of LC350189(tablet or capsule formulations) will be administered with a washout period of at least 4-day between the doses to investigate the relative bioavailability of LC350189 after administration via tablet formulation compared with capsule formulation and to evaluate basic systemic pharmacokinetic parameters of the tablet formulation compared to the capsule formulation of LC350189.

Conditions

• Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	LC350189 Tablet	Subject will receive an LC350189 Tablet as single dose on Day 1 or Day 5
DRUG	LC350189 Capsule	Subject will receive an LC350189 Capsule as single dose on Day 1 or Day 5

Timeline

• Start date: 2021-07-31
• Primary completion: 2021-09-16
• Completion: 2021-12-10
• First posted: 2021-05-13
• Last updated: 2022-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study