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A Study Evaluating the Bioavailability of Oral Insulin (N11005)

NCT04975022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-07-28

No results posted yet for this study

Summary

The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.

Conditions

  • PK, PD, and Safety

Interventions

DRUG

N11005

oral insulin N11005, 300IU, p.o.

DRUG

Novolin R

reference preparation Novolin R, 0.1 IU/Kg, i.h.

Sponsors & Collaborators

  • Beijing Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2020-08-14
Completion
2020-08-14

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 NCT04975022 on ClinicalTrials.gov