The Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects

March 2, 2017 updated by: Jae-Gook Shin, Inje University

An Open-label, Randomized, Crossover Study to Evaluate the Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects

The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy adult male volunteers, ages 19 to 45 years at the time of screening test inclusive.
  2. Subjects who did not have congenital or chronic diseases and sign and symptom after medical examinations
  3. Body Mass Index (BMI) of 18 to 25 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2.
  4. Volunteers deemed as appropriate subjects by investigators, after passing medical screening, including assessment of medical history, vital signs, 12-lead ECG, physical examination, laboratory tests etc. according to the characteristics of the investigational products.
  5. Subjects who can participate in the whole clinical trial.
  6. Subjects who voluntarily sign a written consent form after having received information regarding the objectives and contents of the trial, and characteristics of the study drug drugs prior to signing.

Exclusion Criteria:

  1. Medical History

    1. Subjects with any disease or history of clinically significant liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncologic system, urinary system, cardiovascular system including arrhythmia.
    2. Subjects with any history of gastrointestinal diseases/conditions that could impact on the absorption of study drug.

  2. Laboratory Test and ECG Findings

    1. Subjects who show, or have had clinical abnormalities detected through laboratory tests prior to the trial commencement date. Criteria for liver and renal function test are shown below:

      • AST or ALT above 1.25×ULN
      • Total bilirubin above 1.5×ULN
      • Serum creatinine clearance calculated by CKD-EPI below 80mL/min
    2. Subjects who show a clinically significant abnormalities detected through ECG
  3. History of hypersensitivity to the drug including study drug ingredients and other medications (aspirin, antibiotics, etc.) or clinically significant hypersensitivity

  4. Prohibition on Concomitant Drug/Food

    1. Use of ethical-the-counter/herbal preparations or use of over-the-counter medications/vitamin medications within 2 weeks or 1 week prior to study drug administration, respectively
    2. Subjects on any diet which could affected study drug's pharmacokinetics
    3. Subjects who administered the Probenecid, Penicillin G and other drugs which already known has an effect on OAT1 Transporter activity within 2 weeks prior to the first dose.

  5. Blood Donation and Transfusion

    1. Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 60 days prior to study drug administration.
    2. Blood transfusion within 30 days prior to study drug administration.

  6. Other Exclusion Criteria

    1. Alcohol over intake (alcohol > 30g/day) and screening positive for alcohol
    2. Subjects who smoke within 3 months before initiation of clinical trial and subjects who cannot stop smoking during the participation of clinical study
    3. Subjects who cannot stop taking caffeine-containing foods (e.g. coffee, tea, green tea, cocoa, chocolate, soda, coffee milk, energy supplementary beverage, etc.) and alcoholic beverage during the participation of clinical study
    4. Subjects deemed to be inappropriate for the trial as determined by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Tenofovir
Tenofovir disoproxil fumarate 300mg single dose administration
Drug: Tenofovir disoproxil fumarate 300mg
Single oral dose on the first day of each period
Other Names:
  • viread
Experimental: Tenofovir + PAS
Tenofovir disoproxil fumarate 300mg single dose, Para-aminosalicylic acid Ca Granule 5.28 g BID seven dose administration
Drug: Tenofovir disoproxil fumarate 300mg
Single oral dose on the first day of each period
Other Names:
  • viread
Drug: Para-aminosalicylic acid Ca granule 5.28 g
Twice daily oral administration from the first day of each period to the seventh dose
Other Names:
  • Pas Granule Dongindang

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak plasma concentration (Cmax) of tenofovir
Time Frame: 0-84 hours in test and 0-72 hours in reference arm
Cmax of Tenofovir will be compared between test and reference arms.
0-84 hours in test and 0-72 hours in reference arm
Area under the plasma concentration versus time curve (AUC) of tenofovir
Time Frame: 0-84 hours in test and 0-72 hours in reference arm
AUC of tenofovir will be compared between test and reference arms.
0-84 hours in test and 0-72 hours in reference arm

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Volume of distribution of tenofovir
Time Frame: 0-84 hours in test and 0-72 hours in reference arm
0-84 hours in test and 0-72 hours in reference arm
Time of peak plasma concentration(Tmax) of tenofovir
Time Frame: 0-84 hours in test and 0-72 hours in reference arm
0-84 hours in test and 0-72 hours in reference arm
Plasma half-life of tenofovir
Time Frame: 0-84 hours in test and 0-72 hours in reference arm
0-84 hours in test and 0-72 hours in reference arm
Renal clearance of tenofovir
Time Frame: 0-24 hours
0-24 hours
Amount of tenofovir excreted in urine
Time Frame: 0-24 hours
0-24 hours
Peak plasma concentration of PAS
Time Frame: 0-12 hours
0-12 hours
Area under the plasma concentration versus time curve (AUC) of PAS
Time Frame: 0-12 hours
0-12 hours
Renal clearance of PAS
Time Frame: 0-12 hours
0-12 hours
Volume of distribution of PAS
Time Frame: 0-12 hours
0-12 hours
Time of peak plasma concentration of PAS
Time Frame: 0-12 hours
0-12 hours
Plasma half-life of PAS
Time Frame: 0-12 hours
0-12 hours
Amount of PAS excreted in urine
Time Frame: 0-12 hours
0-12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inje University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jae-Gook Shin, MD, PhD, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-0138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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