Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

Официальное название

Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets in Healthy Subjects: A Randomized, Open-Label, Two-Period, Single-dose, Crossover Trial Under Fed Conditions

Обзор

This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.

Вмешательства

• Препарат treatment T (dose 1)
  Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 1)
• Препарат treatment T (dose 2)
  Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 2)
• Препарат treatment R (dose 1)
  Chiglitazar tablets and Metformin extended release tablets (dose 1)
• Препарат treatment R (dose 2)
  Chiglitazar tablets and Metformin extended release tablets (dose 2)

Первичные конечные точки

• Maximum plasma concentration (Cmax) [Срок оценки: Pre-dose and at multiple timepoints post-dose up to 72 hours]
• Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last) [Срок оценки: Pre-dose and at multiple timepoints post-dose up to 72 hours]
• Area Under the Plasma Concentration-Time Curve from time zero to infinity (AUC0-∞) [Срок оценки: Pre-dose and at multiple timepoints post-dose up to 72 hours]

Вторичные конечные точки (6)

• Time to Maximum Plasma Concentration（Tmax） [Срок оценки: Pre-dose and at multiple timepoints post-dose up to 72 hours]
• Elimination Half-life （t1/2） [Срок оценки: Pre-dose and at multiple timepoints post-dose up to 72 hours]
• Apparent Total Clearance （CL/F） [Срок оценки: Pre-dose and at multiple timepoints post-dose up to 72 hours]
• Apparent Volume of Distribution during the terminal phase （Vz/F） [Срок оценки: Pre-dose and at multiple timepoints post-dose up to 72 hours]
• safety assessments： Incidence of Adverse Events (AEs) [Срок оценки: up to Day 13]
• Changes from baseline in laboratory safety parameters （including hematology, serum chemistry, coagulation, and urinalysis） [Срок оценки: up to Day 11]

Критерии участия

Критерии включения

• Healthy male or female participants；
• Age from 18 to 45 years, inclusive；
• Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；
• From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；
• Voluntarily agrees to participate in the study and signs the informed consent form.

Критерии исключения

• Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine/metabolic disorders;
• Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;
• Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;
• Surgery within 3 months prior to screening or planned surgery during the study period;
• Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;
• History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;
• Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;
• Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;
• History of drug or substance abuse, or a positive alcohol or urine drug screening test;
• Intolerance to venipuncture, or a history of fainting in response to needles or blood;
• Fasting blood glucose > 6.1 mmol/L or < 3.9 mmol/L at screening, and/or a history of hypoglycemia/syncope;
• Participation in any interventional clinical trial within 3 months prior to screening;
• Blood donation or significant blood loss (> 200 mL) within 3 months prior to screening;
• Pregnant or lactating women;
• Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;
• Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;
• Excessive daily consumption of tea, coffee, and/or caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;
• Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;
• Glomerular Filtration Rate (GFR) < 90 mL/min/1.73 m²;
• Systolic blood pressure < 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure < 60 mmHg or ≥ 90 mmHg at screening;
• A positive test result at screening for any of the following: Human Immunodeficiency Virus antibody, Treponema pallidum antibody, Hepatitis B surface antigen, or Hepatitis C virus antibody;
• Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;
• Plans to or is required to engage in strenuous physical activity or exercise during the study period;
• Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07412015 · CGZ113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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