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Trial record 31 of 1359 for:    Area Under Curve AND tablet

Clinical Trial to Assess the Safety and Pharmacokinetics of HUG116 Tablet and Viread® Tablet in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02902523
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Huons Co., Ltd.

Brief Summary:
A randomized, open-label, single-dosing, 2x2 crossover study to compare the safety and pharmacokinetics of HUG116 tablet(Tenofovir Disoproxil) with Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: Viread® tablet 300mg Drug: HUG116 tablet 245mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Viread ® tablet 300mg
Tenofovir disoproxil fumarate
Drug: Viread® tablet 300mg
Single dose administration(PO) in the fasted state

Experimental: HUG116 tablet 245mg
Tenofovir disoproxil
Drug: HUG116 tablet 245mg
Single dose administration(PO) in the fasted state




Primary Outcome Measures :
  1. Area Under Curve(AUC)last of Tenofovir [ Time Frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h ]
  2. Maximum of concentration(Cmax) of Tenofovir [ Time Frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h ]

Secondary Outcome Measures :
  1. Area Under Curve(AUC)inf of Tenofovir [ Time Frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h ]
  2. tmax of Tenofovir [ Time Frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h ]
  3. t1/2β of Tenofovir [ Time Frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h ]
  4. Clearance/F of Tenofovir [ Time Frame: 0h(before administration), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72h ]


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 19 to 45, healthy male subjects(at screening)
  • Body weight over 55kg, in the range of calculated Ideal Body Weight ± 20%
  • Subject without a hereditary problems, chronic disease and morbid symptom
  • 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, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
  • Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
  • Volunteer who had hypersensitivity reaction to medicines including Tenofovir
  • Volunteer who has genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance
  • Sitting systolic blood pressure > 140mmHg or < 100mmHg, sitting diastolic blood pressure ≥ 90mmHg or < 60mmHg, pulse ≥ 100 beats per minute
  • Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
  • Have the result of Creatinine clearance is less than 50mL/min(Cockcroft-Gault equation applicable)
  • Have the result of serum test(RPR Ab(VDRL), HBsAg, HCV Ab, Anti HIV(AIDS)) is a positive
  • 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 in the last 3 months and taking a surfeit of caffeine(caffeine>400mg per day)
  • Subjects with planning of dental treatment (tooth extraction, endodontic treatment etc.) and any surgery (aesthetic operation, laser in-situ keratomileusis, laser assisted sub-epithelial keratomileusis etc.) from signed on an informed consent form to post-study visit
  • 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): NCT02902523


Locations
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Korea, Republic of
Huons
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13486
Sponsors and Collaborators
Huons Co., Ltd.

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Responsible Party: Huons Co., Ltd.
ClinicalTrials.gov Identifier: NCT02902523     History of Changes
Other Study ID Numbers: HUG-116 P1
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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