A Phase 1 interventional study of Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil and Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil in Healthy, sponsored by Bukwang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-18.
Sponsored by Bukwang Pharmaceutical · Phase 1, Interventional, and Treatment
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
Bukwang Pharmaceutical is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil
Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
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
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
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
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Bukwang Pharmaceutical