Trials / Withdrawn
WithdrawnNCT04088266
An Open-Label, Single-Center Study to Evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc at Steady State Following Once-daily Administration of CASSIPA® in Opioid Dependent Subjects.
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the exposure-response relationship between the steady-state plasma concentrations of buprenorphine, norbuprenorphine, naloxone, and total naloxone and the change from baseline in QTc prolongation intervals following administration of CASSIPA® sublingual film (16 mg buprenorphine with 4 mg naloxone) to male and female adult subjects initiating treatment of opioid dependence.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | 16 mg buprenorphine with 4 mg naloxone sublingual film | CASSIPA® |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2019-09-12
- Last updated
- 2020-10-08
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04088266. Inclusion in this directory is not an endorsement.