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NCT06901726
PHASE1

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

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

MALE

Age Range

20 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-03-31

Completion Date

2025-06-01

Last Updated

2025-04-03

Healthy Volunteers

Yes

Interventions

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.