Locally Advanced or Metastatic Solid Tumor
Conditions
Keywords
Healthy Volunteers
Brief summary
This study will adopt a Single-center, Single-arm, Open, Fixed Sequence design to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects.
Interventions
DRUGVC004 and Itraconazole
A single dose of VC004 was administered in the period 1. and a single dose of VC004 and Itraconazole coadministration in the period 2.
DRUGVC004 and rifampicin
A single dose of VC004 was administered in the period 1. and a single dose of VC004 and rifampicin coadministration in the period 2.
Sponsors
Jiangsu vcare pharmaceutical technology co., LTD
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Able and willing to give written informed consent before study, and fully understand the study content, process and possible adverse reactions; * Able to complete the study in compliance with the protocol; * Subject (including partner) is willing to voluntarily take effective contraceptive measures from screening through 6 months after the last dose of study drug; * Male and female subjects between the ages of 18 and 45 years, inclusive; * At least 50.0kg for male subjects, 45.0kg for female subjects, with a Body Mass Index between 19.0-26.0 kg/m2, inclusive;
Exclusion criteria
* More than 5 cigarettes per day on average within 3 months prior to screening; * with A history of allergies, including medications, foods, mites, etc., or those known to be potentially allergic to drugs similar to the study drug, or those known to be allergic to itraconazole, rifampicin, or any excipients; * History of drug and/or alcohol abuse (alcoholism defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); history of drug abuse or or have used drugs within the past five years; * Donation or loss of a significant volume of blood (\>400 mL) within 3 months prior to screening;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day1-Day16 | Maximum Observed Plasma Concentration (Cmax) |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC） | Day1-Day16 | — |
Countries
China
Outcome results
None listed