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
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 30
- Primary Endpoint
- Peak plasma concentration (Cmax) of Entecavir.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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.
- •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).
Arms & Interventions
Baraclude Tab. 0.5mg, fasting
Single dose Baraclude Tab. 0.5mg, fasting state
Intervention: Baraclude Tab. 0.5mg, fasting (Drug)
Cavir Tab. 0.5mg, fasting
Single dose Cavir Tab. 0.5mg, fasting state
Intervention: Cavir Tab. 0.5mg, fasting (Drug)
Cavir Tab. 0.5mg, high fatty meal
Single dose Cavir Tab. 0.5mg, high fatty meal
Intervention: Cavir Tab. 0.5mg, high fatty meal (Drug)
Outcomes
Primary Outcomes
Peak plasma concentration (Cmax) of Entecavir.
Time Frame: Within 6 Months After Final Visit of Subject
phamacokinetic parameter
Area under the plasma concentration versus time curve, last (AUClast) of entecavir.
Time Frame: Within 6 Months After Final Visit of Subject.
phamacokinetic parameter
Number of participants with adverse events.
Time Frame: Within 6 Months After Final Visit of Subject
Secondary Outcomes
- Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir.(Within 6 Months After Final Visit of Subject.)
- The time at which the Cmax is observed (Tmax) of entecavir.(Within 6 Months After Final Visit of Subject.)
- Terminal half-life (T1/2) of entecavir.(Within 6 Months After Final Visit of Subject.)
Investigators
Dong-seok Yim
Prof.
Seoul St. Mary's Hospital