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

NCT ID: NCT02586363

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Baraclude Tab. 0.5mg, fasting

Single dose Baraclude Tab. 0.5mg, fasting state

Group Type ACTIVE_COMPARATOR

Baraclude Tab. 0.5mg, fasting

Intervention Type DRUG

After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Cavir Tab. 0.5mg, fasting

Single dose Cavir Tab. 0.5mg, fasting state

Group Type EXPERIMENTAL

Cavir Tab. 0.5mg, fasting

Intervention Type DRUG

After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Cavir Tab. 0.5mg, high fatty meal

Single dose Cavir Tab. 0.5mg, high fatty meal

Group Type EXPERIMENTAL

Cavir Tab. 0.5mg, high fatty meal

Intervention Type DRUG

After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Interventions

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Baraclude Tab. 0.5mg, fasting

After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Intervention Type DRUG

Cavir Tab. 0.5mg, fasting

After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Intervention Type DRUG

Cavir Tab. 0.5mg, high fatty meal

After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-seok Yim

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Seok Yim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Other Identifiers

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Cavir food effect study

Identifier Type: -

Identifier Source: org_study_id