ClinicalTrials.gg
CompletedNCT00420953Updated Sep 8, 2017

Relative Bioavailability of PM101 IV and Cordarone IV

A Phase 1 interventional study of Cordarone in Healthy, sponsored by Prism Pharmaceuticals. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-08.

Sponsored by Prism Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Determine the relative bioavailability of PM101 I.V. and Cordarone I.V.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Prism Pharmaceuticals is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be a healthy male or female 18 to 59 years of age, inclusive. Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial and must have a negative serum pregnancy test at screening and upon check-in to the study facility.
  • Have a BMI within the range of 18-35 kg/m2, inclusive.
  • Be able to communicate effectively with the study personnel.
  • Have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit or on admission to the clinic.
  • Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction and including normal QTc segment time, i.e. \<430 for males and \<450 for females.
  • Be nonsmokers defined as not having smoked in the past 6 months prior to dosing.
  • Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication.

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity or allergy to Cordarone I.V. or its excipients.
  • Known hypersensitivity or allergy to iodine or radio-opaque dyes.
  • Women who are pregnant or breast feeding.
  • A history or presence of asthma or other pulmonary disease, thyroid disease (hypo- or hyperthyroidism), hepatitis or other liver disease.
  • Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
  • The presence of abnormal laboratory values which are considered clinically significant.
  • Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2).
  • Received an investigational drug within a period of 30 days prior to enrollment in the study.
  • Received any drug therapy within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion is extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism.
  • Consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
  • A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates.
  • Any history of alcohol abuse, illicit drug use (use of soft drugs [such as marijuana] within 3 months prior to screening visit or hard drugs [such as cocaine, phencyclidine [PCP] and crack] within 1 year prior to the screening visit), significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
  • A history of difficulty with donating blood.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double

Interventions

06

What researchers measure

Primary outcomes

  1. Relative bioavailability and safety

07

Study locations

1 site
  • Anapharm
    Montreal, Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00420953
Lead sponsor
Prism Pharmaceuticals
First posted
Jan 11, 2007
Start date
Dec 18, 2006
Primary completion
Apr 23, 2007
Completion
Apr 23, 2007
Last update
Sep 8, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Amiodarone

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