Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05681273

Enrollment

Registered

2023-01-12

Start date

2023-02-17

Completion date

2023-03-21

Last updated

2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T2DM

Brief summary

This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy subjects.

Interventions

DRUGChiglitazar

Chiglitazar 48mg

DRUGEmpagliflozin

Empagliflozin 10mg

DRUGAtorvastatin

Atorvastatin 20mg

DRUGValsartan

Valsartan 160mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects between the ages of 18 and 45 years, inclusive; * 19.0≤BMI≤26.0 kg/m2. Weight of male ≥50 kg and Weight of female ≥ 45 kg.

Exclusion criteria

* History of clinically significant allergy or atopic allergic disease, or allergy to the study drug; * Previous surgery may affect drug absorption, distribution, metabolism and excretion; or have suffered from gastrointestinal, liver and kidney diseases that can affect drug absorption or metabolism in the past 6 months; * History of tuberculosis; * Frequent infection history in the past year, or serious infections leading to hospitalization within 3 months before administration; * untreated diarrhea, or diarrhea within 7 days before administration; * Any drugs, vitamin products or herbal medicine used within 1 month before administration; * History of drug abuse; * Participated in clinical trial within 3 months before administration; * Blood donation or massive blood loss within 3 months before the first administration; * Pregnant or lactating women; * Regular drinking history; or took any alcoholic products within 48 hours before administration; or positive alcohol test; * Regular smoking history within 3 months before administration or cannot quit smoking during the trial; * GFR\<80 mL/min; * Abnormal results of laboratory examination,vital signs, 12 lead ECG, physical examination and chest X-ray; * Systolic blood pressure\<90 or ≥ 140 mmHg, diastolic blood pressure\<60 or ≥ 90 mmHg; * Other situations that are not suitable for participate the study.

Design outcomes

Primary

Measure	Time frame	Description
Cmax	up to 72 hours	Maximum plasma concentration
AUC0-t and AUC0-inf	up to 72 hours	Area under of the curve (AUC0-t and AUC0-inf)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026