Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites

NCT01956487 | Completed Phase 1

• 1 other identifier: 116371
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites

Conditions

Arrhythmia, Cardiac

Keywords

Bioequivalence; RYTHMOL SR®; Atrial fibrillation; Propafenone; Pharmavokinetics

Outcome Measures

Primary Outcomes (1)

• Bioequvalence

  Two formulations of propafenone hydrochloride

  48 hours

Secondary Outcomes (2)

• Pharmacokinetics

  48 hours

• Adverse events

  48 hours

Study Arms (1)

Propafenone

OTHER

Open label comparison of 2 formulations

Drug: Propafenone

Interventions

Propafenone DRUG

Comparison of drug from 2 manufacturing sites

Propafenone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
• Body weight greater than or equal to 50kg and BMI within the range 18.5 - 31.0kg/m2 (inclusive).
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
• AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• A female subject is eligible to participate if she postmenopausal or on a stable regimine of an approved contracetive
• Capable of giving written informed consent,

You may not qualify if:

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
• A positive test for HIV antibody.
• History of regular alcohol consumption within 6 months of the study defined as:an average weekly intake of \>14 drinks for males or \>7 drinks for females. One drink is equivalent to 12g of alcohol: 12 ounces (360ml) of beer, 5 ounces (150ml) of wine or 1.5 ounces (45ml) of 80 proof distilled spirits.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: either 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• The subject has donated blood or blood products in excess of 500mL within a 56 day period.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
• Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
• Lactating females.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Subject is mentally or legally incapacitated.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Baltimore, Maryland, 21225, United States

Location

Related Publications (1)

• "RYTHMOL is a registered trademark of G. Petrik used under license by Abbott Laboratories."

  BACKGROUND

Related Links

• Results for study 116371 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Propafenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: October 8, 2013
• Study Start: April 11, 2012
• Primary Completion: June 27, 2012
• Study Completion: June 27, 2012
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)