Healthy
Conditions
Keywords
Entecavir, Food effect, Cavir Tab 0.5mg, Baraclude Tab. 0.5mg
Brief 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.
Interventions
DRUGBaraclude Tab. 0.5mg, fasting
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
DRUGCavir Tab. 0.5mg, fasting
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
DRUGCavir Tab. 0.5mg, high fatty meal
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
Sponsors
Seoul St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration (Cmax) of Entecavir. | Within 6 Months After Final Visit of Subject | phamacokinetic parameter |
| Area under the plasma concentration versus time curve, last (AUClast) of entecavir. | Within 6 Months After Final Visit of Subject. | phamacokinetic parameter |
| Number of participants with adverse events. | Within 6 Months After Final Visit of Subject | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir. | Within 6 Months After Final Visit of Subject. | Pharmacokinetic parameter |
| The time at which the Cmax is observed (Tmax) of entecavir. | Within 6 Months After Final Visit of Subject. | Pharmacokinetic parameter, Cmax is the peak plasma concentration. |
| Terminal half-life (T1/2) of entecavir. | Within 6 Months After Final Visit of Subject. | Pharmacokinetic parameter |
Outcome results
None listed