Clinical trial · Interventional
TGRX-326 Pharmacokinetic Food Effect Bioavailability Study
A Randomized, Open-label, Single-dose, 3-cycle, 6-sequence, Crossover Study Evaluating Food Effect on Pharmacokinetic Profiles of TGRX-326 in Chinese Healthy Subjects and Effect of Drug Specification on Bioavailability in Human
NCT06304805CI-TRIAL-00089916completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cycle 1: fasted | Behavioral | — | UNRESOLVED |
| cycle 1: food | Behavioral | — | UNRESOLVED |
| cycle 1: reference drug | Drug | — | UNRESOLVED |
| cycle 1: treatment drug | Drug | — | UNRESOLVED |
| cycle 2: fasted | Behavioral | — | UNRESOLVED |
| cycle 2: food | Behavioral | — | UNRESOLVED |
| cycle 2: reference drug | Drug | — | UNRESOLVED |
| cycle 2: treatment drug | Drug | — | UNRESOLVED |
| cycle 3: fasted | Behavioral |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Group A
- description
- cycle 1: treatment drug + fasted cycle 2: reference drug + fasted cycle 3: treatment drug + food
- interventionNames
- Drug: cycle 1: treatment drug
- Behavioral: cycle 1: fasted
- Drug: cycle 2: reference drug
- Behavioral: cycle 2: fasted
- Drug: cycle 3: treatment drug
- Behavioral: cycle 3: food
- type
- EXPERIMENTAL
- label
- Group B
- description
- cycle 1: reference drug + fasted cycle 2: treatment drug + food cycle 3: treatment drug + fasted
- interventionNames
- Drug: cycle 1: reference drug
- Behavioral: cycle 1: fasted
- Drug: cycle 2: treatment drug
- Behavioral: cycle 2: food
- Drug: cycle 3: treatment drug
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * able to understand the purpose, methods and possible adverse events of the study and agree to volunteering consent before the start of study * healthy subject; male or female * Age between 18 and 55 (inclusive) * body mass index (BMI) between 19.0 and 26.0 (inclusive), male weight \<=50 kg, female weight \<=45 kg * normal/ clinically insignificant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.) * participant/partner of the participant does not have plans for child bearing from screening until 6 months after study, and is willing to take contraceptive measures during study period and for 6 months, and does not have plans to donate sperm/egg during the said period Exclusion Criteria: * history of allergic reactions, or allergic to any components to the study drugs that by investigator's judgement unsuitable for the study * any clinically significant conditions that could affect study outcomes, safety or compliance * history of major surgery within 3 months before first dose, or have plans to receive surgery during the study, or history of any surgery that could affect drug absorption, distribution, metabolism and excretion * have difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness * history of substance abuse * have special food requirement or cannot follow food requirement of the study, or lactose intolerant * use of any investigational drug or participation of any clinical study (for drug or medical device) within 3 months before first dose, or cannot participate the study in person/on site * history of blood donation, blood loss (\>= 400 mL, excluding normal blood loss during female menstrual period), or reception of blood transfusion within 3 months before screening * history of daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study * history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or cannot avoid alcohol consumption during study * history of large tea/coffee/caffeinated drink intake (more than 8 cups per day) within 3 months before first dose * history of irregular dietary schedule within 1 months of first dose (including, dieting, overeating, low sodium intake, etc.) * use of any prescription / over-the-counter drug, or Chinese herbal medication, or health supplementary products within 14 days of test article administration * vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period * any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody * alcohol breathing test results of \> 0.0 mg/100mL for blood alcohol concentration * positive test results on substance use (including, morphine, methylamphetamine, ketamine, tetrahydrocannabinol, methylene-dioxy-methyl-amphetamine) * female in pregnancy or breastfeeding period, or positive pregnancy test result * history of unprotected sexual activities within 14 days before first dose * consumption of food or drink rich in caffeine/xanthine (such as chocolate, coffee, tea, coke) or food/food product of grapefruit, dragon fruit, mango, tangerine, or any food that could affect drug absorption, distribution, metabolism and excretion * any reasons that is deemed unsuitable for study participation as determined by investigator
References
Publications (0)
Data not yet available
No reference posted for this study.