Pilot 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 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.

Eligibility criteria

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • treatment T (dose 1)

    Drug

    Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 1)

  • treatment T (dose 2)

    Drug

    Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 2)

  • treatment R (dose 1)

    Drug

    Chiglitazar tablets and Metformin extended release tablets (dose 1)

  • treatment R (dose 2)

    Drug

    Chiglitazar tablets and Metformin extended release tablets (dose 2)

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Treatment Sequence T-R (dose 1)Experimental treatment 2 interventions
Group B: Treatment Sequence R-T (dose 1)Experimental treatment 2 interventions
Group C: Treatment Sequence T-R (dose 2)Experimental treatment 2 interventions
Group D: Treatment Sequence R-T (dose 2)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum plasma concentration (Cmax)

Time frame
Pre-dose and at multiple timepoints post-dose up to 72 hours
2

Area Under the Plasma Concentration-Time Curve from time zero to the last measurable concentration (AUC0-last)

Time frame
Pre-dose and at multiple timepoints post-dose up to 72 hours
3

Area Under the Plasma Concentration-Time Curve from time zero to infinity (AUC0-∞)

Time frame
Pre-dose and at multiple timepoints post-dose up to 72 hours

Secondary outcomes

1

Time to Maximum Plasma Concentration(Tmax)

Time frame
Pre-dose and at multiple timepoints post-dose up to 72 hours
2

Elimination Half-life (t1/2)

Time frame
Pre-dose and at multiple timepoints post-dose up to 72 hours
3

Apparent Total Clearance (CL/F)

Time frame
Pre-dose and at multiple timepoints post-dose up to 72 hours
4

Apparent Volume of Distribution during the terminal phase (Vz/F)

Time frame
Pre-dose and at multiple timepoints post-dose up to 72 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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