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Relative Bioavailability of PM101 IV and Cordarone IV

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ClinicalTrials.gov Identifier: NCT00420953
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : September 8, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
Determine the relative bioavailability of PM101 I.V. and Cordarone I.V.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cordarone Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, 2-period Crossover Trial to Determine the Relative Bioavailability of PM101 I.V. (Amiodarone HCl) and Cordarone I.V. in Healthy Adult Volunteers
Actual Study Start Date : December 18, 2006
Primary Completion Date : April 23, 2007
Study Completion Date : April 23, 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Relative bioavailability and safety

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420953


Locations
Canada, Quebec
Anapharm
Montreal, Quebec, Canada
Sponsors and Collaborators
Prism Pharmaceuticals
More Information

ClinicalTrials.gov Identifier: NCT00420953     History of Changes
Other Study ID Numbers: 101
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors