Pharmacokinetics and Food Effect of HDM1002 , a Novel Oral Small‐Molecule GLP ‐1 Receptor Agonist, in Healthy Chinese Volunteers: A Bioequivalence Study
Authors' conclusion
HDM1002 was well-tolerated and safe. The two tablet strengths (100 and 200 mg) were bioequivalent under fasting conditions. A high-fat meal modestly reduced the C max of the 200-mg tablet but did not significantly affect its overall exposure (AUC).
Study context
- Population
- Healthy Chinese volunteerscrossover
- Participants
- 33 volunteers
- Comparison
- Two 100-mg tablets vs one 200-mg tablet fasting; 200-mg tablet fed vs fasted
- Primary endpoint
- PK, relative bioavailability (90% CI of GMR of Cmax, AUC0-t, AUC0-∞) and food effect of two tablet strengths of HDM1002
Methodological detailsphase I, single-centre, open-label, single-dose, two-formulation, three-period, double-crossover, Washout period of 7 days, Plasma HDM1002 by HPLC-MS/MS; PK by non-compartmental analysis
- Phase I
- Single-centre
- Open-label
- Single-dose
- Two-formulation
- Three-period
- Double-crossover
- Washout period of 7 days
- Plasma HDM1002 by HPLC-MS/MS; PK by non-compartmental analysis
Primary result
As reported in the abstract
Bioequivalence, two 100-mg tablets vs one 200-mg tablet, fasting
GMR Cmax
106.87%
90% CI 91.42%–124.92%
A
GMR AUC0-t
99.64%
90% CI 95.32%–104.15%
A
GMR AUC0-∞
99.55%
90% CI 95.20%–104.09%
A
Further findings
| Outcome | Estimate |
|---|---|
| Food effect on 200-mg tablet (fed vs fasted)C vs B · lower limit slightly below 80.00% | GMR Cmax 87.53% (90% CI 76.88%–99.66%) |
| Food effect on 200-mg tablet (fed vs fasted)C vs B · within the range | GMR AUC0-t 105.90% (90% CI 99.80%–112.37%) |
| Food effect on 200-mg tablet (fed vs fasted)C vs B · within the range | GMR AUC0-∞ 106.01% (90% CI 99.92%–112.47%) |
Safety
- Serious adverse events (AEs)
- 0
Original publication
Pharmacokinetics and Food Effect of HDM1002 , a Novel Oral Small‐Molecule GLP ‐1 Receptor Agonist, in Healthy Chinese Volunteers: A Bioequivalence Study. Diabetes Obes Metab. Published 17 June 2026. doi:10.
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