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Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD

NCT03392961 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-01-23

No results posted yet for this study

Summary

A study to evaluate the PK and PD of oral IN-105 (Insulin Tregopil) w.r.t. time of dosing prior to meal, duration between meals and type of meal .

Conditions

Interventions

DRUG

IN-105 (Insulin Tregopil)

15 mg strength tablets for oral use used at a dose of 30 mg

OTHER

Placebo comparator

Placebo tablet for oral use

Sponsors & Collaborators

  • Biocon Limited

    lead INDUSTRY

Principal Investigators

  • Juan Carlos Rondon, M.D,JD · Elite Research Institute, 15705 NW 13th Avenue, Miami, Florida 33169

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-27
Primary Completion
2014-07-01
Completion
2014-07-01
FDA Drug
Yes

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Entities

Diseases

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 NCT03392961 on ClinicalTrials.gov