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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)

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ClinicalTrials.gov Identifier: NCT01581242
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical

April 18, 2012
April 20, 2012
September 18, 2012
April 2012
June 2012   (Final data collection date for primary outcome measure)
  • AUClast [ Time Frame: Predose ~24hrs ]
  • Cmax [ Time Frame: Predose~24hrs ]
Same as current
Complete list of historical versions of study NCT01581242 on ClinicalTrials.gov Archive Site
  • AUCinf [ Time Frame: Predose~24hrs ]
  • Tmax [ Time Frame: Predose~24hrs ]
  • T1/2 [ Time Frame: Predose~24hrs ]
  • CL/F [ Time Frame: Predose~24hrs ]
  • Safety [ 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
Same as current
Not Provided
Not Provided
 
A Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects
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.
To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy or Adefovir and Clevudine combination in healthy male subjects
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • 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
  • 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;
  • 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
  • Experimental: A
    Intervention: Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil
  • Experimental: B
    Intervention: Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
  • Experimental: C
    Intervention: Drug: Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Same as current
Not Provided
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01581242
BKP-1003
No
Not Provided
Not Provided
Bukwang Pharmaceutical
Bukwang Pharmaceutical
Not Provided
Not Provided
Bukwang Pharmaceutical
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP