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Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males
Sponsor: Shanghai Jiao Tong University School of Medicine
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
Official title: 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
Key Details
Gender
MALE
Age Range
20 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-07-17
Completion Date
2025-10-30
Last Updated
2025-05-16
Healthy Volunteers
Yes
Conditions
Interventions
Human insulin enteric coated capsules in dose 16mg
Single oral administration of human insulin enteric coated capsules in dose 16mg
Human insulin enteric coated capsules in dose 8mg
Single oral administration of human insulin enteric coated capsules in dose 16mg
Human Insulin Injection in dose 5IU
Single subcutaneous administration of Human Insulin Injection in dose 5IU
Locations (1)
uijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China