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

Seoul St. Mary's Hospital

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Cavir Tab. 0.5mg, fasting; Drug: Baraclude Tab. 0.5mg, fasting; Drug: Cavir Tab. 0.5mg, high fatty meal

Study type: Interventional

Funder types: Other

Identifiers

NCT02586363

Cavir food effect study

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Baraclude Tab. 0.5mg, fasting

Active Comparator group

Description:

Single dose Baraclude Tab. 0.5mg, fasting state

Treatment:

Drug: Baraclude Tab. 0.5mg, fasting

Cavir Tab. 0.5mg, fasting

Experimental group

Description:

Single dose Cavir Tab. 0.5mg, fasting state

Treatment:

Drug: Cavir Tab. 0.5mg, fasting

Cavir Tab. 0.5mg, high fatty meal

Experimental group

Description:

Single dose Cavir Tab. 0.5mg, high fatty meal

Treatment:

Drug: Cavir Tab. 0.5mg, high fatty meal