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

NCT02586363 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-12-03

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Seoul St. Mary's Hospital

    lead OTHER

Principal Investigators

  • Dong-Seok Yim, MD, PhD · Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02586363 on ClinicalTrials.gov