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Completed

NCT Number: NCT02557594

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Viread 300mg

Drug

single dose administration after 10hr fasting

Other names: Tenofovir disoproxil fumarate

DA-2802 319mg

Drug

single dose administration after 10hr fasting

Other names: Tenofovir disoproxil orotate

Primary outcomes

  1. Area Under Curve(AUC)last of Tenofovir

    Time frame: 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

  2. Maximum of concentration(Cmax) of Tenofovir

    Time frame: 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 outcomes

  1. Time of maximum concentration(Tmax) of Tenofovir

    Time frame: 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

  2. Terminal half-life(t1/2) of Tenofovir

    Time frame: 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

  3. Apparent Clearance(CL/F) of Tenofovir

    Time frame: 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

  4. Area Under Curve(AUC)inf of Tenofovir

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Two-way Crossover Study to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg After a Single Oral Dose in Healthy Male Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 23, 2015
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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