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Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects

NCT05528120 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-11-30

No results posted yet for this study

Summary

This study will adopt a randomized, open-label, two-period, 2-way crossover design to evaluate pharmacokinetics of a single oral dose of VC004 capsules under fasting and fed conditions in healthy subjects.

Conditions

  • Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Interventions

DRUG

VC004 Capsules

Oral administration after fasting/high-fat meal

DRUG

VC004 Capsules

Oral administration after high-fat/fasting meal

Sponsors & Collaborators

  • Jiangsu vcare pharmaceutical technology co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2022-10-28
Completion
2022-11-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05528120 on ClinicalTrials.gov