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

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

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 Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: Baraclude Tab. 0.5mg, fasting; Drug: Cavir Tab. 0.5mg, fasting; Drug: Cavir Tab. 0.5mg, high fatty meal

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Baraclude Tab. 0.5mg, fasting; Single dose Baraclude Tab. 0.5mg, fasting state	Drug: Baraclude Tab. 0.5mg, fasting; After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
Experimental: Cavir Tab. 0.5mg, fasting; Single dose Cavir Tab. 0.5mg, fasting state	Drug: Cavir Tab. 0.5mg, fasting; After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
Experimental: Cavir Tab. 0.5mg, high fatty meal; Single dose Cavir Tab. 0.5mg, high fatty meal	Drug: Cavir Tab. 0.5mg, high fatty meal; After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Investigators: Principal Investigator: Dong-Seok Yim, MD, PhD, Seoul St. Mary's hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Food effect; Entecavir; Cavir Tab 0.5mg; Baraclude Tab. 0.5mg
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Entecavir
• Other Study ID Numbers: Cavir food effect study