NCT06901726

Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males

An Open, Randomized, Single Dose (32mg), Two-way Crossover Study on Pharmacokinetics, Pharmacodynamics, Relative Biopotency and Bioavailability of Human Insulin Enteric Coated Capsules in Healthy Chinese Male Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Pharmacokinetics and pharmacodynamics study of 2 formulations (human insulin enteric coated capsules 32mg vs. human insulin injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 32mg vs. human insulin injection 5IU

Detailed description

An open, randomized, single dose, two-way crossover study on Pharmacokinetics, pharmacodynamics, relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic-euglycemic clamp.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Human insulin enteric coated capsules in dose 32mg	Single oral administration of human insulin enteric coated capsules in dose 32mg (16 mg per capsule, two capsules).
DRUG	Human Insulin Injection in dose 5IU	Single subcutaneous administration of Human Insulin Injection in dose 5IU.

Timeline

• Start date: 2025-03-31
• Primary completion: 2025-04-24
• Completion: 2025-06-01
• First posted: 2025-03-30
• Last updated: 2025-04-03