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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.

2019-09-18 03:27:40 | BioPortfolio

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.

Study Design

Conditions

Evaluation of QTc Interval

Intervention

16 mg buprenorphine with 4 mg naloxone sublingual film

Status

Not yet recruiting

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-18T03:27:40-0400

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESIC with naloxone, a NARCOTIC ANTAGONIST to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIATE SUBSTITUTION THERAPY.

A form of retention cyst of the floor of the mouth, usually due to obstruction of the ducts of the submaxillary or sublingual glands, presenting a slowly enlarging painless deep burrowing mucocele of one side of the mouth. It is also called sublingual cyst and sublingual ptyalocele.

Use of a device (film badge) for measuring exposure of individuals to radiation. It is usually made of metal, plastic, or paper and loaded with one or more pieces of x-ray film.

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

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