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

Phase 1

• Conditions: Healthy
• Interventions: Drug: Baraclude Tab. 0.5mg, fasting; Drug: Cavir Tab. 0.5mg, fasting; Drug: Cavir Tab. 0.5mg, high fatty meal

• Registration Number: NCT02586363
• Lead Sponsor: Seoul St. Mary's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-26
• Study Start: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Baraclude Tab. 0.5mg, fasting	Baraclude Tab. 0.5mg, fasting	Single dose Baraclude Tab. 0.5mg, fasting state
Cavir Tab. 0.5mg, fasting	Cavir Tab. 0.5mg, fasting	Single dose Cavir Tab. 0.5mg, fasting state
Cavir Tab. 0.5mg, high fatty meal	Cavir Tab. 0.5mg, high fatty meal	Single dose Cavir Tab. 0.5mg, high fatty meal

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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