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

S

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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