Study to assess the safety and pharmacokinetics of DA-2802 319 mg and Viread® 300 mg in healthy male volunteers
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0001678
- Lead Sponsor
- Dong-A ST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 36
•Age between 20 to 50, healthy male subjects(at screening)
•Body weight over 55kg, BMI between 18.0 - 27.0
•Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
•Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, urinary, skeletomuscular, cardiovascular, mental disorder)
•Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
•Genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance which is contraindication to Viread
•Volunteer who had hypersensitivity reaction to medicines including Tenofovir, Aspirin, or antibiotics
•exceed 1.5 times the normal range of AST, ALT at screening test before randomization
•history of drug abuse, or a positive urine drug screen
•having ethical drug or herbal medicines within 2 weeks before first administration or over the conter drug or vitamin preparations within a week before first administration
•Participation in any other clinical trial involving investigational drugs within 3 months
•Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
•Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
•Volunteers smoking over 10 cigarettes per day or who cannot abstain from smoking during the study(from 24hr before admission to discharge)
•Volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods
•Volunteers who are not using adequate contraception methods or have a pregnancy plan
•volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study
•any condition that, in the view of the investigator, would interfere with study participation
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast, Cmax
- Secondary Outcome Measures
Name Time Method Tmax, t1/2, CL/F, AUCinf;Vital sign;Adverse event;Physical examination;Electrocardiography;Laboratory test