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

NCT02300688 | Completed Phase 1

• 1 other identifier: ID_BVCL013
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

Period 1 (Treatment A) - Wash out - Period 2 (Treatment B)

Drug: Treatment A; Drug: Treatment B

Arm 2

EXPERIMENTAL

Period 1 (Treatment B) - Wash out - Period 2 (Treatment A)

Drug: Treatment A; Drug: Treatment B

Interventions

Treatment A DRUG

administration of 1 time administration of the test drug (Treatment A)

Also known as: LB80380 maleate made by IDP

Arm 1; Arm 2

Treatment B DRUG

administration of 1 time administration of the reference drug (Treatment B)

Also known as: LB80380 maleate made by LGLS

Arm 1; Arm 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male whose age is 19 years or more and 55 years or less in full at the time of screening test
• Subjects whose body mass index is 19 kg/m2 or more and 27 kg/m2 or less at the time of screening test
• 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
• Subjects who have ability and volition to participate in the Clinical Trial in the entire period of it

You may not qualify if:

• 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
• Subjects who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Subjects who have medical history of hypersensitivity to the drugs (aspirin, antibiotics) or have allergic diseases that require treatment
• Subjects who were administered to investigational product within the past 60 days from the day of random allocation
• 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
• 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)
• Subjects whose average drinking quantity per week exceeds alcohol 140g
• Subjects whose average smoking quantity exceeds 20 cigarettes or subjects who cannot stop smoking during their hospitalization
• Subjects whose average quantity of intake of grapefruit juice per day exceeds 4 glasses
• 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
• Subjects whose AST, ALT, total bilirubin, γ-glutamyl transferasevalues in blood exceed 1.5 times of the upper limit of reference
• Subjects whose Creatine phosphokinase value in blood exceeds 2.5 times of the upper limit of reference
• Subjects whose glomerular filtration rate calculated from creatinine value in blood is less than 60 mL/min.
• Subjects who do not show negative reaction in tests for hepatitis B, tests for hepatitis C, HIV test and tests for syphilis
• Subjects who show positive reaction in urine drug screening test

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeong-Ryeol Kim, Ph D.

  Samsung Medical Center, Professor of department of clinical pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 13, 2016

Record last verified: 2016-01