Bioequivalence Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers

An Open Label, Randomized, 2-sequence, 2-period, Single-dose Cross-over Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers

After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Treatment A; Drug: Treatment B

Detailed Description

The purpose of this study is to evaluate equivalence of bioavailability of LB80331 preparations different. Following the randomly allocated sequence group administer the relevant test drug for 1 time according to the determined schedule of Treatment A and Treatment B in each of the periods.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male whose age is 19 years or more and 55 years or less in full at the time of screening test
2. Subjects whose body mass index is 19 kg/m2 or more and 27 kg/m2 or less at the time of screening test
3. Subjects who listened to sufficient explanation of the purpose and contents of the Clinical Trial and characteristics of the test drug and spontaneously agreed to participate in the study in writing
4. Subjects who have ability and volition to participate in the Clinical Trial in the entire period of it

Exclusion Criteria:

1. Subjects who have clinically significant diseases or medical history of the diseases such as hepatobiliary, gastrointestinal, urinary, respiratory, cardiovascular system, musculoskeletal, endocrine system, neuropsychiatric disease, blood disease and tumor
2. Subjects who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
3. Subjects who have medical history of hypersensitivity to the drugs (aspirin, antibiotics) or have allergic diseases that require treatment
4. Subjects who were administered to investigational product within the past 60 days from the day of random allocation
5. Subjects who donated whole blood within the past 60 days from the day of random allocation or donated component blood within the past 30 days from the day of random allocation
6. Subjects who took the drug which needs doctor's prescription or oriental herbal medicine within the past 14 days from the day of random allocation or took over-the-counter drug within the past 7 days from the day of random allocation (Only, can be selected as subject according to decision of the investigator)
7. Subjects whose average drinking quantity per week exceeds alcohol 140g
8. Subjects whose average smoking quantity exceeds 20 cigarettes or subjects who cannot stop smoking during their hospitalization
9. Subjects whose average quantity of intake of grapefruit juice per day exceeds 4 glasses
10. Subjects whose systolic blood pressure is less than 90 mmHg or more than 140 mmHg or diastolic pressure is less than 60 mmHg or more than 100 mmHg at the time of screening test
11. Subjects whose AST, ALT, total bilirubin, γ-glutamyl transferasevalues in blood exceed 1.5 times of the upper limit of reference
12. Subjects whose Creatine phosphokinase value in blood exceeds 2.5 times of the upper limit of reference
13. Subjects whose glomerular filtration rate calculated from creatinine value in blood is less than 60 mL/min.
14. Subjects who do not show negative reaction in tests for hepatitis B, tests for hepatitis C, HIV test and tests for syphilis
15. Subjects who show positive reaction in urine drug screening test
16. Subjects who were decided to be not suitable for participation in the Clinical Trial by investigators for other reasons

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Period 1 (Treatment A) - Wash out - Period 2 (Treatment B)	Drug: Treatment A; administration of 1 time administration of the test drug (Treatment A); Other Names: LB80380 maleate made by IDP; Drug: Treatment B; administration of 1 time administration of the reference drug (Treatment B); Other Names: LB80380 maleate made by LGLS
Experimental: Arm 2; Period 1 (Treatment B) - Wash out - Period 2 (Treatment A)	Drug: Treatment A; administration of 1 time administration of the test drug (Treatment A); Other Names: LB80380 maleate made by IDP; Drug: Treatment B; administration of 1 time administration of the reference drug (Treatment B); Other Names: LB80380 maleate made by LGLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUClast	preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
Cmax	preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax	preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
t1/2	preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose
AUCinf	preodse, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 hours post-dose

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd
• Investigators: Principal Investigator: Jeong-Ryeol Kim, Ph D., Samsung Medical Center, Professor of department of clinical pharmacology

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Estimate): January 13, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Maleic acid
• Other Study ID Numbers: ID_BVCL013