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MainTitle

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

This study has been completed
Sponsor
Dong-A ST Co., Ltd.


Information provided by (Responsible Party)
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier
NCT02557594

First received: September 22, 2015
Last updated: April 10, 2017
Last Verified: April 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Healthy

Drug : Viread 300mg
Drug : DA-2802 319mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures

  • 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 ]
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 36
Study Start Date: October 6, 2015
Study Completion Date: March 8, 2016
Primary Completion Date: November 17, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Viread → DA-2802
Viread 300mg(Tenofovir disoproxil fumarate) DA-2802 319mg(Tenofovir disoproxil orotate)
Drug: Viread 300mg

single dose administration after 10hr fasting

Other Name: Tenofovir disoproxil fumarate
Drug: DA-2802 319mg

single dose administration after 10hr fasting

Other Name: Tenofovir disoproxil orotate
Experimental: DA-2802 → Viread
Viread 300mg(Tenofovir disoproxil fumarate) DA-2802 319mg(Tenofovir disoproxil orotate)
Drug: Viread 300mg

single dose administration after 10hr fasting

Other Name: Tenofovir disoproxil fumarate
Drug: DA-2802 319mg

single dose administration after 10hr fasting

Other Name: Tenofovir disoproxil orotate
Eligibility

Eligibility

Ages Eligible for Study: 20 Years to 50 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02557594

Locations

Korea, Republic of
Clinical Trial Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Dong-A ST Co., Ltd.

Investigators

Principal Investigator: Kyung-sang Yu, Ph.D, M.B.A Seoul National University Hospital
More Information

More Information


Responsible Party: Dong-A ST Co., Ltd.  
ClinicalTrials.gov Identifier: NCT02557594   History of Changes  
Other Study ID Numbers: DA2802_BE_I  
Study First Received: September 22, 2015  
Last Updated: April 10, 2017  

Keywords provided by Dong-A ST Co., Ltd.:

Hepatitis B

Additional relevant MeSH terms:
Tenofovir

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.