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)

Bukwang Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil

Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil

Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01581242

BKP-1003

Details and patient eligibility

About

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.

Full description

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

Enrollment

42 estimated patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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