Clinical trial NCT02586363: Study of Evaluation of Cavir Tab. 0.5mg With Food Effect on Pharmacokinetics and Safety
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Entecavir
Food effect
Cavir Tab 0.5mg
Baraclude Tab. 0.5mg
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Peak plasma concentration (Cmax) of Entecavir.
timeFrame: Within 6 Months After Final Visit of Subject
measure: Area under the plasma concentration versus time curve, last (AUClast) of entecavir.
timeFrame: Within 6 Months After Final Visit of Subject.
measure: Number of participants with adverse events.
timeFrame: Within 6 Months After Final Visit of Subject
Secondary outcomes:
measure: Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir.
timeFrame: Within 6 Months After Final Visit of Subject.
measure: The time at which the Cmax is observed (Tmax) of entecavir.
timeFrame: Within 6 Months After Final Visit of Subject.
measure: Terminal half-life (T1/2) of entecavir.
timeFrame: Within 6 Months After Final Visit of Subject.
Other outcomes:
Locations:
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Dong-Seok Yim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: