Overview

This trial is active, not recruiting.

Condition healthy
Treatments baraclude tab. 0.5mg, fasting, cavir tab. 0.5mg, fasting, cavir tab. 0.5mg, high fatty meal
Phase phase 1
Sponsor Seoul St. Mary's Hospital
Start date November 2015
End date March 2016
Trial size 30 participants
Trial identifier NCT02586363, Cavir food effect 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
Single dose Baraclude Tab. 0.5mg, fasting state
baraclude tab. 0.5mg, fasting
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
(Experimental)
Single dose Cavir Tab. 0.5mg, fasting state
cavir tab. 0.5mg, fasting
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
(Experimental)
Single dose Cavir Tab. 0.5mg, high fatty meal
cavir tab. 0.5mg, high fatty meal
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Primary Outcomes

Measure
Peak plasma concentration (Cmax) of Entecavir.
time frame: Within 6 Months After Final Visit of Subject
Area under the plasma concentration versus time curve, last (AUClast) of entecavir.
time frame: Within 6 Months After Final Visit of Subject.
Number of participants with adverse events.
time frame: Within 6 Months After Final Visit of Subject

Secondary Outcomes

Measure
Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir.
time frame: Within 6 Months After Final Visit of Subject.
The time at which the Cmax is observed (Tmax) of entecavir.
time frame: Within 6 Months After Final Visit of Subject.
Terminal half-life (T1/2) of entecavir.
time frame: Within 6 Months After Final Visit of Subject.

Eligibility Criteria

Male or female participants from 19 years up to 45 years old.

Inclusion Criteria: - Healthy male, aged 19 ~ 45 at screening date - Subject`s weight is in range from -120 percentage to +120 percentage of ideal body weight which is calculated by { height (cm) - 100} * 0.9. - The Subject is willing and able to provide written informed consent to participate in the study Exclusion Criteria: - Subject has a history of clinically significant disease. - Subject has a digestive disease (Crohn`s disease, ulcer, acute or chronic pancreatitis etc) or abdomen surgery (exclude, simple appendectomy or hernia operation). - Subject has a hypersensitivity history which is clinically significance or additives. - Subject is inappropriate to screening (disease history, physical examination, vital sings, electrocardiogram, laboratory test etc.) - Subject has a laboratory test result as indicated by and one of the following. - serum aspartate aminotransferase> 1.25 * normal limit - serum Total bilirubin > 1.5 * normal upper limit - serum CPK > 1.5 * normal upper limit - eGFR(estimated Glomerular Filtration Rate) calaulated by MDRD (Modification of Diet in Renal Disease) formula < 60 mL/min/1.73m2 - Subject is hypertension(SBP>140mmHg or DBP>90mmHg) or hypotension(SBP<90mmHg, DBP<60mmHg) - Subject has a drug abusing history. - Subject is currently abusing alcohol (more than 210 g/week), caffeine(more than 5cups/day) or smoking(more than half pack).

Additional Information

Official title 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
Principal investigator Dong-Seok Yim, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Seoul St. Mary's Hospital.