Healthy Volunteers
Conditions
Keywords
Tenofovir Disoproxil Fumarate, 4-Aminosalicylic Acid, Tuberculosis, HIV
Brief summary
The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir.
Interventions
Single oral dose on the first day of each period
DRUGPara-aminosalicylic acid Ca granule 5.28 g
Twice daily oral administration from the first day of each period to the seventh dose
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration (Cmax) of tenofovir | 0-84 hours in test and 0-72 hours in reference arm | Cmax of Tenofovir will be compared between test and reference arms. |
| Area under the plasma concentration versus time curve (AUC) of tenofovir | 0-84 hours in test and 0-72 hours in reference arm | AUC of tenofovir will be compared between test and reference arms. |
Secondary
| Measure | Time frame |
|---|---|
| Plasma half-life of tenofovir | 0-84 hours in test and 0-72 hours in reference arm |
| Renal clearance of tenofovir | 0-24 hours |
| Amount of tenofovir excreted in urine | 0-24 hours |
| Peak plasma concentration of PAS | 0-12 hours |
| Area under the plasma concentration versus time curve (AUC) of PAS | 0-12 hours |
| Volume of distribution of tenofovir | 0-84 hours in test and 0-72 hours in reference arm |
| Volume of distribution of PAS | 0-12 hours |
| Time of peak plasma concentration of PAS | 0-12 hours |
| Plasma half-life of PAS | 0-12 hours |
| Amount of PAS excreted in urine | 0-12 hours |
| Renal clearance of PAS | 0-12 hours |
| Time of peak plasma concentration(Tmax) of tenofovir | 0-84 hours in test and 0-72 hours in reference arm |
Outcome results
None listed