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Arrhythmia, CardiacPhase 1NCT01956487

Bioequivalence of RYTHMOL SR® Manufactured at Two Different Sites

A Phase 1 study testing Propafenone in people with Arrhythmia, Cardiac, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Arrhythmia, Cardiac
What is being tested?
Propafenone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
11 Apr 2012to 27 Jun 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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,

Who cannot join

  • 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).
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  • 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.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
  • Unwilling to abstain from alcohol for 48 hours prior to screening and 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
  • Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy, peptic ulceration, inflammatory bowel disease or pancreatitis should be excluded.
  • The subject's systolic blood pressure is outside the range of 90-140 mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 55-100bpm for female subjects or 50-100bpm for male subjects.
  • Screening ECG within normal limts for age and gender
  • Evidence of previous myocardial infarction.
  • Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome, non-sustained or sustained ventricular tachycardia (3 or more consecutive ventricular ectopic beats), sinus pauses > 3 seconds, or other significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Crossover Study to Demonstrate the Bioequivalence of RYTHMOL SR® (Propafenone Hydrochloride) Manufactured at Two Different Sites

Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites

Read the detailed description

This will be a Phase 1, randomized, open-label, single-dose, three-period, crossover study to assess the bioequivalence of propafenone hydrochloride manufactured at two different sites in healthy adult volunteers. Approximately 36 subjects will receive a 3 single doses of propafenone hydrochloride 425mg, each administered separately, in the fasted state with a 7 day washout period between doses. Propafenone hydrochloride is an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients with episodic (most likely paroxysmal or persistent) atrial fibrillation who do not have structural heart disease. A follow-up visit will occur 7-10 days after the final dose of study drug.

Being tested
Propafenone
Keywords
Bioequivalence, RYTHMOL SR®, Atrial fibrillation, Propafenone, Pharmavokinetics
Medical subject headings
Arrhythmias, Cardiac, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropafenoneDrug

    Comparison of drug from 2 manufacturing sites

Study groups in NCT01956487
Study groupRoleWhat they receive
PropafenoneOtherOpen label comparison of 2 formulations
Receives: Drug: Propafenone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bioequvalence

    Two formulations of propafenone hydrochloride

    Measured: 48 hours

Secondary outcomes (2)

  1. Pharmacokinetics

    Plasma AUC and Cmax of propafenone

    Measured: 48 hours

  2. Adverse events

    Safety and Tolerability

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2013 (estimated)
  2. Study start11 Apr 2012
  3. Primary completion27 Jun 2012
  4. Study completion27 Jun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01956487
Sponsor's protocol ID
116371
Status last verified
Jun 2017
First submitted
19 Jul 2012
Last updated
12 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Propafenone in people with Arrhythmia, Cardiac, run by GlaxoSmithKline at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bioequvalence (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01956487, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.

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