Healthy
Conditions
Keywords
Hepatitis B
Brief summary
This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose in healthy male volunteers.
Interventions
DRUGViread 300mg
single dose administration after 10hr fasting
DRUGDA-2802 319mg
single dose administration after 10hr fasting
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 ETC drug or herbal medicines within 2 weeks before first administration or OTC 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under Curve(AUC)last of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
| Maximum of concentration(Cmax) of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum concentration(Tmax) of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
| Terminal half-life(t1/2) of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
| Apparent Clearance(CL/F) of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
| Area Under Curve(AUC)inf of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
Countries
South Korea
Outcome results
None listed