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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01581242
First received: April 18, 2012
Last updated: September 16, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil
Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
Drug: Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • AUClast [ Time Frame: Predose ~24hrs ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: Predose~24hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCinf [ Time Frame: Predose~24hrs ] [ Designated as safety issue: Yes ]
  • Tmax [ Time Frame: Predose~24hrs ] [ Designated as safety issue: No ]
  • T1/2 [ Time Frame: Predose~24hrs ] [ Designated as safety issue: No ]
  • CL/F [ Time Frame: Predose~24hrs ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Screening, predose, post 24h, Post-study visit ] [ Designated as safety issue: No ]
    clinically measured adverse events, abnormality of laboratory tests abnormality of vital signs,ECG e.t.c


Estimated Enrollment: 42
Study Start Date: April 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581242

Locations
Korea, Republic of
Clinical Trial Center, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

No publications provided

Responsible Party: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01581242     History of Changes
Other Study ID Numbers: BKP-1003
Study First Received: April 18, 2012
Last Updated: September 16, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Bukwang Pharmaceutical:
Clevudine and Adefovir dipivoxil
pharmacokinetic drug drug interaction
oral administration
male subjects

Additional relevant MeSH terms:
Adefovir
Adefovir dipivoxil
Clevudine
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014