A Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects (BKP-1003-101)

A Randomized, Open-label, Three-sequence, Three-period, Three-treatment Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects

This is a randomized, open-label, three-sequence, three-period, three-treatment clinical trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir dipivoxil after oral administration in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil; Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil; Drug: Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil

Detailed Description

To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy or Adefovir and Clevudine combination in healthy male subjects

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Clinical Trial Center, Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Age limit is from 20 to 45 with healthy male subjects in screening
• Weight limit is from 50kg(110.23Ib) to 90kg(198.41Ib) with BMI 18.5-26 (BMI(kg/m2)= weight(kg)/{height(m)}2
• The person who fully understands and listens about this clinical trial, receives written consent to observe the notandum and decides to participate voluntarily

Exclusion Criteria:

• The person who has past history or serious disease in liver, kidney, nervous system, respiratory system, gastro-intestinal tract system, endocrine system, blood tumor, cardio-vascular system, urinary system, mental system clinically
• The person who has the past history of Gastro-intestinal operation(except simple appendectomy or herniotomy)or Gastro-intestinal system disease (Chron's disease,ulcer,acute and chronic pancreatitis, etc) that can be influenced the absorption of clinical drug
• The person who has the past history of hypersensitivity reaction about the drugs that contain the identical affiliation ingredient or ingredient of Clevudine, Adefovir dipivoxil or others drugs(aspirin, antibiotics etc)or has the significant past history of hypersensitivity reaction clinically
• The person who shows results of the 1.5 times upper limit in screening test of AST(SGOT), ALT(SGPT)
• The person who shows results of the positive HBsAg, HCV Ab,HIV Ab
• The person who has a past history of drug abuse or shows a positive result of drug abuse in urine drug analysis of screening test
• The person who takes medications of some medicine and medical supplies or oriental medicine within 2 weeks before the first administration date', or some OTC drug, vitamin supplements or health functional food within 1week (if only,it's confirmed by the investigator's judgment that they are not affected in pharmacokinetics character and safety evaluation about the clinical drugs)
• The person who participates in other clinical trials within 2 weeks before the first administration date'
• The person who donates plasma pheresis within 1 month before the first administration date, donates whole blood within 2 months before the first administration date or receives a transfusion within a month before the first administration date
• Persistent drinker(over 21 units/week, 1 unit = 10g of pure alcohol) or a drinker who can't stop drinking during hospitalization period
• Smoker who takes a drag over 10 cigarettes per day during the past three months
• The person who was judged unfit for participating in clinical trials by a investigator because of the clinical laboratory test results or other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil; Clevudine 20mg qd Days 1; Adefovir dipivoxil 10 mg qd Days 8;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 15
Experimental: B	Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil; Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 1; Clevudine 20mg qd Days 8; Adefovir dipivoxil 10 mg qd Days 15;
Experimental: C	Drug: Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil; Adefovir dipivoxil 10 mg qd Days 1;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 8; Clevudine 20mg qd Days 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUClast	Predose ~24hrs
Cmax	Predose~24hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf		Predose~24hrs
Tmax		Predose~24hrs
T1/2		Predose~24hrs
CL/F		Predose~24hrs
Safety	clinically measured adverse events, abnormality of laboratory tests abnormality of vital signs,ECG e.t.c	Screening, predose, post 24h, Post-study visit

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 16, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: oral administration; pharmacokinetic drug drug interaction; male subjects; Clevudine and Adefovir dipivoxil
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Adefovir; Adefovir dipivoxil; Clevudine
• Other Study ID Numbers: BKP-1003