A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Both males and females
Description
This is a 2-period crossover study and consists of two cohorts. Cohort 1 consists of participant's with greater than or equal to (>=) 40.0 kilogram (kg) to lesser than or equal to (<=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (>) 75.0 kg to <= 120.0 kg of weight. Pa...
This is a 2-period crossover study and consists of two cohorts. Cohort 1 consists of participant's with greater than or equal to (>=) 40.0 kilogram (kg) to lesser than or equal to (<=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (>) 75.0 kg to <= 120.0 kg of weight. Participants in each cohort will be randomized to 1 of 2 treatment periods (Period I and Period II) with sequence AB and BA. Randomization will be stratified by injection site (i.e., thigh, abdomen, and arm) within each cohort.
Tracking Information
- NCT #
- NCT04465396
- Collaborators
- Takeda Development Center Americas, Inc.
- Investigators
- Study Director: Study Director Takeda Development Center Americas, Inc.
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