Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06519604
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 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

Interventions

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

Locations (1)

uijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China