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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baraclude Tab. 0.5mg, fasting | Active Comparator | Single dose Baraclude Tab. 0.5mg, fasting state |
|
| Cavir Tab. 0.5mg, fasting | Experimental | Single dose Cavir Tab. 0.5mg, fasting state |
|
| Cavir Tab. 0.5mg, high fatty meal | Experimental | Single dose Cavir Tab. 0.5mg, high fatty meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baraclude Tab. 0.5mg, fasting | Drug | After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of Entecavir. | phamacokinetic parameter | Within 6 Months After Final Visit of Subject |
| Area under the plasma concentration versus time curve, last (AUClast) of entecavir. | phamacokinetic parameter | Within 6 Months After Final Visit of Subject. |
| Number of participants with adverse events. | Within 6 Months After Final Visit of Subject |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir. | Pharmacokinetic parameter | Within 6 Months After Final Visit of Subject. |
| The time at which the Cmax is observed (Tmax) of entecavir. |
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Inclusion Criteria:
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.
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).
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Seok Yim, MD, PhD | Seoul St. Mary's Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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| Cavir Tab. 0.5mg, fasting | Drug | After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration) |
|
| Cavir Tab. 0.5mg, high fatty meal | Drug | After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration) |
|
Pharmacokinetic parameter, Cmax is the peak plasma concentration.
| Within 6 Months After Final Visit of Subject. |
| Terminal half-life (T1/2) of entecavir. | Pharmacokinetic parameter | Within 6 Months After Final Visit of Subject. |