Clinical Trial Center, Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT01581242
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.
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Notify Me20 year–45 year
Male
Interventional
Phase 1
Seoul, South Korea
To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy or Adefovir and Clevudine combination in healthy male subjects
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Predose ~24hrs
Time frame: Predose~24hrs
Time frame: Predose~24hrs
Time frame: Predose~24hrs
Time frame: Predose~24hrs
Time frame: Predose~24hrs
Time frame: Screening, predose, post 24h, Post-study visit
clinically measured adverse events, abnormality of laboratory tests abnormality of vital signs,ECG e.t.c
Bukwang Pharmaceutical
Industry
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
Acronym: BKP-1003-101
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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