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

NCT ID: NCT03070405

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-05-31

Brief Summary

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Tenofovir

Tenofovir disoproxil fumarate 300mg single dose administration

Group Type: ACTIVE_COMPARATOR

Tenofovir disoproxil fumarate 300mg

Intervention Type: DRUG

Single oral dose on the first day of each period

Tenofovir + PAS

Tenofovir disoproxil fumarate 300mg single dose, Para-aminosalicylic acid Ca Granule 5.28 g BID seven dose administration

Group Type: EXPERIMENTAL

Tenofovir disoproxil fumarate 300mg

Intervention Type: DRUG

Single oral dose on the first day of each period

Para-aminosalicylic acid Ca granule 5.28 g

Intervention Type: DRUG

Twice daily oral administration from the first day of each period to the seventh dose

Interventions

Tenofovir disoproxil fumarate 300mg

Single oral dose on the first day of each period

Intervention Type: DRUG

Para-aminosalicylic acid Ca granule 5.28 g

Twice daily oral administration from the first day of each period to the seventh dose

Intervention Type: DRUG

Other Intervention Names

viread; Pas Granule Dongindang

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Inje University

OTHER

Sponsor Role: lead

Responsible Party

Jae-Gook Shin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae-Gook Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Other Identifiers

16-0138

Identifier Type: -

Identifier Source: org_study_id