NCT04767815

To Evaluate Food Effect on the PK and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The pharmacokinetics (PK) and safety of single oral dose of DWN12088 in healthy adults will be compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat meal.

Detailed description

The pharmacokinetics and safety of single oral dose of DWN12088 in healthy adults will be compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat meal.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Diet A group	Fasting + DWN12088 200 mg
DRUG	Diet B group	30 minutes after a high-fat meal + DWN12088 200 mg
DRUG	Diet C group	2 hours after a high-fat meal + DWN12088 200 mg

Timeline

• Start date: 2021-03-22
• Primary completion: 2021-05-31
• Completion: 2021-06-04
• First posted: 2021-02-23
• Last updated: 2021-08-10

Locations

1 site across 1 country: South Korea