NCT02586363

Study of Evaluation of Cavir Tab. 0.5mg With Food Effect on Pharmacokinetics and Safety

A Randomized, Open-label, 3-way Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics and Safety of Single-dose Cavir Tab. 0.5mg With Baraclude Tab. 0.5mg in Healthy Male Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

In this clinical trial, the investigator will clarify the difference in pharmacokinetics between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high fatty meal for healthy adult volunteer. The investigators evaluate the effect of food intake on the absorption of Cavir Tab. 0.5mg.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Baraclude Tab. 0.5mg, fasting	After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
DRUG	Cavir Tab. 0.5mg, fasting	After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
DRUG	Cavir Tab. 0.5mg, high fatty meal	After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-10-26
• Last updated: 2015-12-03