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.

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.

Publication date: Sep 12, 2019

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(R) sublingual film (16 mg buprenorphine with 4 mg naloxone) to male and female adult subjects initiating treatment of opioid dependence.

Concepts Keywords
Alcohol Buprenorphine products
Allergy Allergy
ALT Respiratory COPD
Amiodarone Orthostatic hypotension
Amphetamines Active myocardial ischemia
Antiarrhythmic TBI
Anticholinergic Uncontrolled hypertension
Antiretroviral Drugs Hypersensitivity
AST Condition organ dysfunction
Asthma Idiopathic intracranial hypertension
Asymptomatic IgM active Hepatitis
Atrial Fibrillation Pressure choledocholithiasis
Atrioventricular Asymptomatic Hepatitis
AV Block Drug delivery system
Barbiturates Contraception
Barrier Method Hysterectomy
Benzodiazepine Surgery
Benzodiazepines Opioids
Blood Drugs
BMI Psychoactive drugs
Body Mass Index RTT
Bradycardia Morphinans
Buprenorphine Drug rehabilitation
Cardiac Arrhythmias Euphoriants
Cardiac Disease Ketones
Cardiovascular Buprenorphine
Cerebrospinal Fluid Opioid use disorder
Cocaine Substance dependence
Congenital Methadone
Congestive Heart Failure AV
Contraception Drug delivery system
COPD
Cor Pulmonale
Cytochrome P450 3A4
Diastolic Blood Pressure
Diuretics
Doxepin
Drug Delivery
DSM
ECG
Electrolyte
Endocrine
Eszopiclone
FDA
Formula
Fredericia
FSH
Gastrointestinal
Gonadotropin
HBsAg
Hepatic
HIV
Hormonal Contraceptive
Hormonal Contraceptives
Hydrocephalus
Hydrocodone
Hypersensitivity
Hypertension
Hypocalcaemia
Hypokalemia
Hypomagnesaemia
Hypotensive
Hysterectomy
Idiopathic Intracranial Hypertension
IgM
Infectious Disease
Informed Consent
Intrauterine Device
Lactating
Left Ventricular Hypertrophy
Liver
MAOI
MDMA
Menses
Methadone
Methamphetamine
Mirtazapine
Monoamine Oxidase Inhibitors
Myocardial Infarction
Myocardial Ischemia
Naloxone
Neoplasm
Neurotransmitter System
Norepinephrine
Oophorectomy
Opiate
Opioid
Opioid Dependence
Opioids
Organ
Orthostatic Hypotension
Pharmacologic
Physical Exam
Plasma
Postmenopausal
Pregnancy
Procainamide
Protocol
Pulmonary
QTc Interval
Quinidine
Receptor
Renal
Reuptake
Serotonergic
Serotonin
Serum
Sexual Partner
SNRIs
Sotalol
SSRIs
Sterilization
Sublingual
Suicidal Ideation
Suicide
Sumatriptan
Supine
Syndrome
Systolic Blood Pressure
TdP
Test Sensitivity
Teva
Tobacco
Total Abstinence
Tramadol
Transdermal
Traumatic Brain Injury
Tricyclic Antidepressants
Triptans
Tubal Ligation
Urine
Zaleplon
Zolpidem

Semantics

Type Source Name
drug DRUGBANK Buprenorphine
drug DRUGBANK Naloxone
disease MESH opioid dependence
drug DRUGBANK Follitropin
drug DRUGBANK Chorionic Gonadotropin (Human)
disease MESH diagnosis
disease MESH substance use disorder
disease MESH neoplasm
disease DOID neoplasm
disease MESH hydrocephalus
disease DOID hydrocephalus
disease MESH idiopathic intracranial hypertension
disease DOID idiopathic intracranial hypertension
disease MESH choledocholithiasis
disease DOID choledocholithiasis
disease MESH COPD
disease DOID COPD
gene UNIPROT ARCN1
disease MESH asthma
disease DOID asthma
pathway BSID Asthma
disease MESH cor pulmonale
disease DOID cor pulmonale
disease MESH diuretics
disease MESH Suicidal ideation
gene UNIPROT YES1
disease MESH suicide
disease MESH allergy
disease DOID allergy
disease MESH drug hypersensitivity
disease MESH renal
disease MESH infectious disease
disease DOID infectious disease
pathway BSID Infectious disease
disease DOID cancer
disease MESH abnormalities
disease MESH cardiac arrhythmias
disease MESH AV block
disease DOID AV block
disease MESH left bundle branch block
disease MESH cardiac disease
disease MESH hypertension
disease DOID hypertension
disease MESH atrial fibrillation
disease DOID atrial fibrillation
disease MESH bradycardia
disease MESH congestive heart failure
disease DOID congestive heart failure
disease MESH myocardial infarction
disease DOID myocardial infarction
disease MESH myocardial ischemia
disease MESH left ventricular hypertrophy
disease MESH congenital
disease MESH Torsade de Pointes
drug DRUGBANK Thiocolchicoside
drug DRUGBANK Quinidine
drug DRUGBANK Procainamide
drug DRUGBANK Disopyramide
drug DRUGBANK Flecainide
drug DRUGBANK Propafenone
drug DRUGBANK Sotalol
drug DRUGBANK Amiodarone
drug DRUGBANK Dofetilide
drug DRUGBANK Ibutilide
drug DRUGBANK Dronedarone
disease MESH hypokalemia
disease DOID hypokalemia
disease MESH orthostatic hypotension
disease MESH syncopal episodes
gene UNIPROT CYP3A4
drug DRUGBANK Serotonin
gene UNIPROT OR2AG1
drug DRUGBANK Mirtazapine
drug DRUGBANK Tramadol
drug DRUGBANK Sumatriptan
drug DRUGBANK Zolmitriptan
drug DRUGBANK Methadone
drug DRUGBANK Ethanol
drug DRUGBANK Benzodiazepine
drug DRUGBANK Eszopiclone
drug DRUGBANK Zaleplon
drug DRUGBANK Zolpidem
drug DRUGBANK Doxepin
drug DRUGBANK Ramelteon
drug DRUGBANK Suvorexant
disease MESH Hepatitis B
disease DOID Hepatitis B
pathway BSID Hepatitis B
drug DRUGBANK Hepatitis B Vaccine (Recombinant)
disease MESH Hepatitis C
disease DOID Hepatitis C
pathway BSID Hepatitis C
gene UNIPROT SLC17A5
drug DRUGBANK Hydrocodone
drug DRUGBANK Cocaine
drug DRUGBANK Metamfetamine
drug DRUGBANK Midomafetamine
gene UNIPROT NR4A2
gene UNIPROT ALG3

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