CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
Teduglutide +2 moredrug
Likely dose
Teduglutide 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04465396
NCT04465396Phase 1Completed
CompareCT.gov

A Randomized, Open-label, Two-treatment, Two-period, Single-dose, Crossover Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Subjects

Shire·interventional·Posted Jul 10, 2020·Updated Oct 4, 2022

In Brief

A Phase 1 clinical trial evaluating Teduglutide, Syringe Injection, and 1 other intervention for Healthy Volunteers. Completed, enrolled 64 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the bioavailability of teduglutide administered as a single subcutaneous (SC) fixed dose (depending upon participant weightband assignment) delivered by a syringe injection and the same fixed dose delivered by the pen injector in healthy participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsTakeda Development Center Americas, Inc.

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 10, 2020
Enrollment StartJan 13, 2021
Primary CompletionAug 20, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.0 years ago

Interventions

Teduglutidedrug

Participants received 3 mg or 4 mg of Teduglutide SC syringe injection followed by pen injector or vice versa depending upon the treatment sequence AB or BA on Day 1 of Treatment Periods 1 and 2.

Syringe Injectiondevice

Teduglutide was administered using syringe.

Pen injectordevice

Teduglutide was administered using pen injector.