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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03070405
Other study ID # 16-0138
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received February 9, 2017
Last updated March 2, 2017
Start date October 2016
Est. completion date May 2017

Study information

Verified date February 2017
Source Inje University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date May 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Tenofovir disoproxil fumarate 300mg
Single oral dose on the first day of each period
Para-aminosalicylic acid Ca granule 5.28 g
Twice daily oral administration from the first day of each period to the seventh dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Inje University

Outcome

Type Measure Description Time frame Safety issue
Primary Peak plasma concentration (Cmax) of tenofovir Cmax of Tenofovir will be compared between test and reference arms. 0-84 hours in test and 0-72 hours in reference arm
Primary Area under the plasma concentration versus time curve (AUC) of tenofovir AUC of tenofovir will be compared between test and reference arms. 0-84 hours in test and 0-72 hours in reference arm
Secondary Volume of distribution of tenofovir 0-84 hours in test and 0-72 hours in reference arm
Secondary Time of peak plasma concentration(Tmax) of tenofovir 0-84 hours in test and 0-72 hours in reference arm
Secondary Plasma half-life of tenofovir 0-84 hours in test and 0-72 hours in reference arm
Secondary Renal clearance of tenofovir 0-24 hours
Secondary Amount of tenofovir excreted in urine 0-24 hours
Secondary Peak plasma concentration of PAS 0-12 hours
Secondary Area under the plasma concentration versus time curve (AUC) of PAS 0-12 hours
Secondary Renal clearance of PAS 0-12 hours
Secondary Volume of distribution of PAS 0-12 hours
Secondary Time of peak plasma concentration of PAS 0-12 hours
Secondary Plasma half-life of PAS 0-12 hours
Secondary Amount of PAS excreted in urine 0-12 hours
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