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Trial record 39 of 3226 for:    Area Under Curve AND Healthy

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

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ClinicalTrials.gov Identifier: NCT02557594
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Viread 300mg Drug: DA-2802 319mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Actual Study Start Date : October 6, 2015
Actual Primary Completion Date : November 17, 2015
Actual Study Completion Date : March 8, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557594


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

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02557594     History of Changes
Other Study ID Numbers: DA2802_BE_I
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
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Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents