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NCT06024915CompletedPhase 1

A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets

A Phase I Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets

Source: ClinicalTrials.gov · Last updated 12 Dec 2025

Brief summary (registry, in English)

This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of metabolic enzyme inhibitors/inducers on in vivo metabolic and elimination of TQ05105 tablets, and the safety of metabolic enzyme inhibitors/inducers combined with TQ05105 tablets.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
40 (actual)
First submitted
30 Aug 2023
Start date
21 Sept 2023
Primary completion date
29 Jan 2024
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NCT number
NCT06024915

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 40
  • From 21 Sept 2023 to the primary completion date, 29 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects who drank regularly in the 6 months prior to first dosing, such as those who drank more than 14 units of alcohol per week or who had a positive alcohol breath test at the time of screening;
  • Subjects who had a history of major surgery, or had taken the study drug, or had participated in other drug clinical trials within 3 months prior to initial dosing;
  • Subjects who donated blood or lost significant amounts of blood within 3 months prior to initial dosing;
  • Subjects who had used drugs within 3 months prior to first dosing, or tested positive for drugs, or had a history of drug abuse within 5 years prior to screening;
  • Subjects who smoked more than 5 cigarettes per day in the 3 months prior to initial dosing or who could not stop using any tobacco products during the trial;
  • Subjects who consumed excessive amounts of tea, coffee, and/or caffeinated beverages daily in the 30 days prior to initial dosing;
  • Subjects who have used any drug that inhibits or induces liver metabolism of the drug in the 30 days prior to initial dosing;
  • Subjects who have taken any prescription, over-the-counter, herbal, or health product in the 14 days prior to initial dosing;
  • Subjects who have taken a special diet or other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to initial dosing;

Other illness

  • Subjects: preexisting or existing circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic disorders or abnormalities, or related chronic or acute diseases, the investigator assesses that it is not appropriate to participate in the trial;
  • Subjects with Systemic/local acute infection before taking the study drug;
  • Subjects who have a history of specific allergies, or allergic conditions (such as allergies to two or more drugs, environments, or foods), or are known to be allergic to components or analogs of the study drug;
  • Subjects who have difficulty in swallowing or have any gastrointestinal disorder that affects drug absorption at the time of screening;

Other

  • Subjects who cannot receive venous indwelling needle for blood sample collection;
  • Subjects who ingested chocolate, any caffeinated, or xanthine-rich food or drink 48 hours before first dosing;
  • Subjects who have special dietary requirements and cannot follow a uniform diet;
  • Female subjects of child-bearing potential;
  • Subjects judged by the investigator to be unsuitable to participate.

Who the study is looking for

  • At the time of signing the informed consent, males or females between 18 and 45 years of age;
  • Female weight ≥ 45 kg, male weight ≥ 50 kg, with a body mass index (BMI) between 19 and 26 kg/m2.
  • Subjects in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations;
  • Subjects can comply with the study procedures, voluntarily participate in the study, and sign the informed consent in person.

Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shandong Provincial Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.