What is the clinical evidence from this study?

Study design: RCT. Population: Healthy volunteers (n=33). Intervention: HDM1002 vs. Alternative formulation or fasting state. Primary outcome: Relative bioavailability (geometric mean ratios for Cmax, AUC0-t, AUC0-∞) (GMR 99.64% for AUC0-t, 95% CI 95.32-104.15).

What question did this study set out to answer?

This research evaluates the pharmacokinetics, bioavailability, and food effects of HDM1002 in healthy volunteers.

June 19, 2026

Pharmacokinetics and Food Effect of HDM1002 , a Novel Oral Small‐Molecule GLP ‐1 Receptor Agonist, in Healthy Chinese Volunteers: A Bioequivalence Study

Key Result

Two 100-mg tablets of HDM1002 were bioequivalent to one 200-mg tablet under fasting conditions (AUC0-t geometric mean ratio 99.64%; 90% CI 95.32-104.15%).

Key Points

This research evaluates the pharmacokinetics, bioavailability, and food effects of HDM1002 in healthy volunteers.
Single-center, randomized, open-label, single-dose, two-formulation, three-period, double-crossover study
Enrolled 33 healthy volunteers (HVs)
Measured plasma concentrations using HPLC-MS/MS and analyzed PK parameters non-compartmentally.
C max and AUC ratios for two 100-mg tablets vs. one 200-mg tablet were within the bioequivalence range (90% CI: 106.87%, 99.64%, and 99.55%)
Food effect resulted in a significant reduction in C max for the 200-mg tablet, but AUC values were still within range
No serious adverse events were reported.

Study Design

Type

RCT (n=33)

Blinding

open-label

Randomization

randomised

Multicenter

Structured PICO

Does HDM1002 show bioequivalence between two 100-mg tablets and one 200-mg tablet, and what is the food effect on the 200-mg tablet in healthy Chinese volunteers?

Population

33 healthy Chinese volunteers enrolled in a phase I crossover study to evaluate the pharmacokinetics, relative bioavailability, and food effects of HDM1002.

Intervention

HDM1002 (novel oral small-molecule GLP-1 receptor agonist) administered as two 100-mg tablets under fasting conditions, a single 200-mg tablet under fasting conditions, or a single 200-mg tablet following a high-fat meal

Comparator

Cross-over comparison between the different formulations (two 100-mg tablets vs. one 200-mg tablet) and fasting/fed states

Outcome

Pharmacokinetics (Cmax, AUC0-t, AUC0-∞) and relative bioavailabilitysurrogate

The 100-mg and 200-mg tablet formulations of the novel oral GLP-1 receptor agonist HDM1002 are bioequivalent under fasting conditions, and a high-fat meal does not significantly affect overall exposure.

Main Result

Effect estimate: GMR 99.64% for AUC0-t (95% CI 95.32-104.15)

Abstract

ABSTRACT Purpose HDM1002 is a potent, orally active, and highly selective small‐molecule full agonist of the glucagon‐like peptide‐1 receptor (GLP‐1R), independently developed by Hangzhou Sino‐American Huadong Pharmaceutical Co. Ltd. Our aim was to evaluate the pharmacokinetics, relative bioavailability, and food effects of two tablet strengths (100 and 200 mg) of HDM1002 in Chinese health volunteers (HVs). Methods This single‐centre, randomised, open‐label, single‐dose, two‐formulation, three‐period, double‐crossover phase I study enrolled 33 HVs. All subjects received each of the following three treatments in different periods: (A) two 100‐mg tablets under fasting conditions; (B) a single 200‐mg tablet under fasting conditions; and (C) a single 200‐mg tablet following a high‐fat meal. A washout period of 7 days was implemented. The plasma concentrations of HDM1002 were measured using HPLC‐MS/MS method, and PK parameters were determined by non‐compartmental analysis. Results Under fasting conditions, the 90% confidence intervals (CI) for the geometric mean ratios (two 100‐mg tablets vs. one 200‐mg tablet) of C max , AUC 0‐t , AUC 0‐∞ were 106.87% (91.42%, 124.92%), 99.64% (95.32%, 104.15%), and 99.55% (95.20%, 104.09%), respectively, all within the 80.00%–125.00% bioequivalence range. For the food effect on the 200‐mg tablet, the 90% CI of C max (fed vs. fasted) was 87.53% (76.88%, 99.66%), with its lower limit slightly below 80.00%; AUC 0‐t and AUC 0‐∞ were 105.90% (99.80%, 112.37%) and 106.01% (99.92%, 112.47%), both within the range. And there were no serious adverse events (AEs) occurred. 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). Trial Registration: ClinicalTrials.gov identifier: ChiCTR2500111569

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