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.
To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy or Adefovir and Clevudine combination in healthy male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Clevudine 20mg qd Days 1; Adefovir dipivoxil 10 mg qd Days 8;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 15
Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 1; Clevudine 20mg qd Days 8; Adefovir dipivoxil 10 mg qd Days 15;
Adefovir dipivoxil 10 mg qd Days 1;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 8; Clevudine 20mg qd Days 15
Clinical Trial Center, Seoul National University Hospital
Seoul, South Korea
AUClast
Time frame: Predose ~24hrs
Cmax
Time frame: Predose~24hrs
AUCinf
Time frame: Predose~24hrs
Tmax
Time frame: Predose~24hrs
T1/2
Time frame: Predose~24hrs
CL/F
Time frame: Predose~24hrs
Safety
clinically measured adverse events, abnormality of laboratory tests abnormality of vital signs,ECG e.t.c
Time frame: Screening, predose, post 24h, Post-study visit
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