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The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir | Active Comparator | Tenofovir disoproxil fumarate 300mg single dose administration |
|
| Tenofovir + PAS | Experimental | Tenofovir disoproxil fumarate 300mg single dose, Para-aminosalicylic acid Ca Granule 5.28 g BID seven dose administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate 300mg | Drug | Single oral dose on the first day of each period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of distribution of tenofovir | 0-84 hours in test and 0-72 hours in reference arm | |
| Time of peak plasma concentration(Tmax) of tenofovir | 0-84 hours in test and 0-72 hours in reference arm | |
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Inclusion Criteria:
Exclusion Criteria:
Medical History
Laboratory Test and ECG Findings
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:
Subjects who show a clinically significant abnormalities detected through ECG
History of hypersensitivity to the drug including study drug ingredients and other medications (aspirin, antibiotics, etc.) or clinically significant hypersensitivity
Prohibition on Concomitant Drug/Food
Blood Donation and Transfusion
Other Exclusion Criteria
Male participants included into the study
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Gook Shin, MD, PhD | Inje University | Principal Investigator |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Para-aminosalicylic acid Ca granule 5.28 g | Drug | Twice daily oral administration from the first day of each period to the seventh dose |
|
|
| 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 |
| Renal clearance of PAS | 0-12 hours |
| 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 |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |