Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2016-03-08
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Tenofovir

Criteria

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