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CompletedNCT01581242BKP-1003-101Updated Sep 18, 2012

A Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects

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

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Healthy

Keywords

  • Clevudine and Adefovir dipivoxil
  • pharmacokinetic drug drug interaction
  • oral administration
  • male subjects
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    A

    Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil

  • Experimental
    B

    Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil

  • Experimental
    C

    Drug: Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil

Interventions

  • DrugClevudine, 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

  • DrugClevudine; 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;

  • DrugClevudine,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

06

What researchers measure

Primary outcomes

  1. AUClast

    Time frame: Predose ~24hrs

  2. Cmax

    Time frame: Predose~24hrs

Secondary outcomes

  1. AUCinf

    Time frame: Predose~24hrs

  2. Tmax

    Time frame: Predose~24hrs

  3. T1/2

    Time frame: Predose~24hrs

  4. CL/F

    Time frame: Predose~24hrs

  5. 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

07

Study locations

1 site
  • Clinical Trial Center, Seoul National University Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01581242
Lead sponsor
Bukwang Pharmaceutical
Responsible party
Sponsor
First posted
Apr 20, 2012
Start date
Apr 2012
Primary completion
Jun 2012
Last update
Sep 18, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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