Pharmacokinetic and Pharmacodynamic Drug-Drug Interactions Between Cofrogliptin and Metformin in Healthy Subjects: A Single-Center, Single-Arm, Phase I Study in China.
Clin Pharmacol Drug DevOct 1, 2026
Clinical ResearchEndocrinology
Cheng Cui, Na Liu, Chang Chu et al.
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In 30 seconds
This single-center, single-arm Phase I study assessed drug-drug interactions between cofrogliptin and metformin in 22 healthy Chinese subjects. The results indicated that cofrogliptin did not significantly affect metformin's pharmacokinetics or pharmacodynamics, with geometric mean ratios for metformin's AUC and C_ss showing no clinically significant changes. Similarly, metformin did not impact cofrogliptin's properties.
Key findings
- Cofrogliptin's GMRs for metformin AUC 0-8 h was 0.872 (90% CI: 0.809, 0.941).
- Metformin's GMRs for cofrogliptin AUC over the dosing interval was 1.12 (90% CI: 1.072, 1.169).
- No serious adverse events or severe hypoglycemia were reported during the study.
- All pharmacokinetic and pharmacodynamic interactions were within the 0.80-1.25 range.
Why it matters
Understanding drug-drug interactions is crucial for optimizing therapy in patients with diabetes. This study provides evidence that cofrogliptin and metformin can be safely combined without significant pharmacokinetic or pharmacodynamic interactions.