Pharmacokinetics and pharmacodynamics of oral insulin ( ORMD ‐0801) in healthy subjects: A phase I study using hyperinsulinaemic‐euglycaemic clamp
Authors' conclusion
This study comprehensively describes the PK/PD characteristics of ORMD-0801 in healthy subjects and provides a basis for future clinical trials.
Study context
- Population
- Healthy Chinese male subjects
- Participants
- 20 subjects
- Comparison
- Oral ORMD-0801 vs subcutaneous (SC) insulin
Methodological detailsphase I, open-label, hyperinsulinaemic-euglycaemic clamp
- Phase I
- Open-label
- Hyperinsulinaemic-euglycaemic clamp
Primary result
As reported in the abstract
Pharmacokinetic (PK)/pharmacodynamic (PD) during 11-h clamp
- GIRmax, 16 mg oral vs SC insulin (mg/kg/min)
- 3.87 ± 1.08 vs 3.51 ± 0.52
- AUCGIR0-11h, 16 mg oral vs SC insulin (h·mg/kg/min)
- 26.98 ± 10.69 vs 23.74 ± 9.04
- GIRmax, 8 mg oral vs SC insulin (mg/kg/min)
- 3.86 ± 1.25 vs 5.41 ± 3.05
- AUCGIR0-11h, 8 mg oral vs SC insulin (h·mg/kg/min)
- 27.07 ± 8.43 vs 29.95 ± 7.70
- SC-equivalent dose, 16 mg (IU)
- 6.53 ± 3.97
- SC-equivalent dose, 8 mg (IU)
- 4.62 ± 1.13
- AUCIns0-∞, 16 mg oral vs SC insulin (h·ng/mL)
- 5.47 ± 3.17 vs 7.50 ± 2.37
- AUCIns0-∞, 8 mg oral vs SC insulin (h·ng/mL)
- 4.86 ± 2.89 vs 7.85 ± 2.02
- Relative bioavailability, 16 mg and 8 mg
- 0.53 ± 0.25% and 0.94 ± 0.77%
Original publication
Pharmacokinetics and pharmacodynamics of oral insulin ( ORMD ‐0801) in healthy subjects: A phase I study using hyperinsulinaemic‐euglycaemic clamp. Diabetes Obes Metab. Published 3 September 2025. doi:10.
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