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

NCT ID: NCT02557594

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-06
• Study Completion Date: 2016-03-08

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Viread → DA-2802

• Viread 300mg(Tenofovir disoproxil fumarate)
• DA-2802 319mg(Tenofovir disoproxil orotate)

Group Type: EXPERIMENTAL

Viread 300mg

Intervention Type: DRUG

single dose administration after 10hr fasting

DA-2802 319mg

Intervention Type: DRUG

single dose administration after 10hr fasting

DA-2802 → Viread

• Viread 300mg(Tenofovir disoproxil fumarate)
• DA-2802 319mg(Tenofovir disoproxil orotate)

Group Type: EXPERIMENTAL

Viread 300mg

Intervention Type: DRUG

single dose administration after 10hr fasting

DA-2802 319mg

Intervention Type: DRUG

single dose administration after 10hr fasting

Interventions

Viread 300mg

single dose administration after 10hr fasting

Intervention Type: DRUG

DA-2802 319mg

single dose administration after 10hr fasting

Intervention Type: DRUG

Other Intervention Names

Tenofovir disoproxil fumarate; Tenofovir disoproxil orotate

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-sang Yu, Ph.D, M.B.A

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Clinical Trial Center, Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DA2802_BE_I

Identifier Type: -

Identifier Source: org_study_id