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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02586363
• Other study ID #: Cavir food effect study
• Status: Active, not recruiting
• Phase: Phase 1
• First received: October 15, 2015
• Last updated: December 1, 2015
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Baraclude Tab. 0.5mg, fasting
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
• Cavir Tab. 0.5mg, fasting
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
• Cavir Tab. 0.5mg, high fatty meal
After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak plasma concentration (Cmax) of Entecavir.	phamacokinetic parameter	Within 6 Months After Final Visit of Subject	No
Primary	Area under the plasma concentration versus time curve, last (AUClast) of entecavir.	phamacokinetic parameter	Within 6 Months After Final Visit of Subject.	No
Primary	Number of participants with adverse events.		Within 6 Months After Final Visit of Subject	No
Secondary	Area under the plasma concentration versus time curve, infinite (AUCinf) of entecavir.	Pharmacokinetic parameter	Within 6 Months After Final Visit of Subject.	No
Secondary	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.	No
Secondary	Terminal half-life (T1/2) of entecavir.	Pharmacokinetic parameter	Within 6 Months After Final Visit of Subject.	No