NCT06519604

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• 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 3 formulations (human insulin enteric coated capsules 8mg vers. human insulin injection 5IU；human insulin enteric coated capsules 16mg vers. Human Insulin Injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg/16mg vers. 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

• Diabete Mellitus

Interventions

Type	Name	Description
DRUG	Human insulin enteric coated capsules in dose 16mg	Single oral administration of human insulin enteric coated capsules in dose 16mg
DRUG	Human insulin enteric coated capsules in dose 8mg	Single oral administration of human insulin enteric coated capsules in dose 16mg
DRUG	Human Insulin Injection in dose 5IU	Single subcutaneous administration of Human Insulin Injection in dose 5IU

Timeline

• Start date: 2024-07-17
• Primary completion: 2024-09-13
• Completion: 2025-10-30
• First posted: 2024-07-25
• Last updated: 2025-05-16

Locations

1 site across 1 country: China