A Study to Assess New Formulations of TEV-56286

Description

The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants. The secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned duration for each participant is approximately 70 days which includes a 45 day screening period.

Conditions

Healthy Participants

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Study Overview

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Study Details

Study overview

The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants. The secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned duration for each participant is approximately 70 days which includes a 45 day screening period.

An Open-Label, Randomized, Crossover Study to Assess the Comparative Bioavailability of New TEV-56286 Formulations Compared to a Reference TEV-56286 Capsule Formulation Following Single-Dose Administration in Healthy Participants

A Study to Assess New Formulations of TEV-56286

Condition
Healthy Participants
Intervention / Treatment

-

Contacts and Locations

Miramar

Teva Investigational Site 12141, Miramar, Florida, United States, 33025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive)
  • * Females of childbearing potential agree to take appropriate measures to prevent pregnancy during the study
  • * Males who do not have a documented vasectomy or are not congenitally sterile must agree to abstinence or use of barrier method with spermicide with female partner. Male participant who is having sexual intercourse with a woman of childbearing potential who is not currently pregnant will be advised of her requirement to use an additional highly effective contraceptive method
  • * NOTE - Additional criteria apply, please contact the investigator for more information
  • * Participation in another clinical trial simultaneously
  • * Females who are lactating, breastfeeding, or intends to become pregnant over the course of the study
  • * History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine)
  • * Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of IMP, or surgery scheduled during the study or follow-up period
  • * Donated blood or blood products (eg, white blood cells \[WBCs\], platelets, etc.) within the 60 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or has donated plasma within 7 days of the screening visit or has received blood or blood products in the 6 weeks before screening
  • * Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope, or previous personal treatment for high blood pressure
  • * NOTE - Additional criteria apply, please contact the investigator for more information

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Teva Branded Pharmaceutical Products R&D LLC,

Teva Medical Expert, MD, STUDY_DIRECTOR, Teva Branded Pharmaceutical Products R&D LLC

Study Record Dates

2025-05-29