NCT06304805 - TGRX-326 Pharmacokinetic Food Effect Bioavailability Study | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

January 12, 2024

Study Completion Date

January 19, 2024

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

Trial Locations (1)

233004

First Affiliated Hospital Bengbu Medical College, Bengbu

All Listed Sponsors

collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

lead

Shenzhen TargetRx, Inc.

INDUSTRY