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

NCT06519604 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-16

No results posted yet for this study

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

Conditions

  • Diabete Mellitus

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

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2024-09-13
Completion
2025-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06519604 on ClinicalTrials.gov