TGRX-326 Pharmacokinetic Food Effect Bioavailability Study

Summary

A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment

Conditions

• Non Small Cell Lung Cancer

Interventions

DRUG

cycle 1: treatment drug

for cycle 1 treatment: participants are given the oral treatment specification (60 mg \*1 pill)

DRUG

cycle 1: reference drug

for cycle 1 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)

BEHAVIORAL

cycle 1: fasted

for cycle 1 treatment: participants are asked to take the drug fasted

BEHAVIORAL

cycle 1: food

for cycle 1 treatment: participants are asked to take the drug after food intake

DRUG

cycle 2: treatment drug

for cycle 2 treatment: participants are given the oral treatment specification (60 mg \*1 pill)

DRUG

cycle 2: reference drug

for cycle 2 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)

BEHAVIORAL

cycle 2: fasted

for cycle 2 treatment: participants are asked to take the drug fasted

BEHAVIORAL

cycle 2: food

for cycle 2 treatment: participants are asked to take the drug after food intake

DRUG

cycle 3: treatment drug

for cycle 3 treatment: participants are given the oral treatment specification (60 mg \*1 pill)

DRUG

cycle 3: reference drug

for cycle 3 treatment: participants are given the oral reference specification (5 mg \*2 pills + 25 mg \* 2 pills)

BEHAVIORAL

cycle 3: fasted

for cycle 3 treatment: participants are asked to take the drug fasted

BEHAVIORAL

cycle 3: food

for cycle 3 treatment: participants are asked to take the drug after food intake

Sponsors & Collaborators

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• Shenzhen TargetRx, Inc.

  lead INDUSTRY

Principal Investigators

• Huan Zhou, MD · The First Affiliated Hospital of Bengbu Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-13

Primary Completion

2024-01-12

Completion

2024-01-19

Countries

• China

Study Locations