Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChipscreen Biosciences, Ltd.

About this trial

This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1
  • Chiglitazar tablet, dose 1
  • Metformin extended-release tablet, dose 1
  • Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 2
  • Chiglitazar tablet, dose 2
  • Metformin extended-release tablet, dose 2

Treatment groups

64 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators