Healthy Participants
Conditions
Brief summary
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.
Interventions
DRUGTEV-56286 Test
Administered orally
DRUGTEV-56286 Reference
Administered orally
Sponsors
Teva Branded Pharmaceutical Products R&D LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Drug Concentration (Cmax) | Up to Day 17 |
| Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)] | Up to Day 17 |
| Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)] | Up to Day 17 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with at least one treatment-emergent adverse event | Up to Day 26 |
| Number of participants who did not complete the trial due to an adverse event | Up to Day 26 |
Countries
United States
Contacts
STUDY_DIRECTORTeva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D LLC
Outcome results
None listed