Relative Bioavailability of PM101 IV and Cordarone IV

This study has been completed.
Sponsor:
Information provided by:
Prism Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00420953
First received: January 8, 2007
Last updated: January 14, 2008
Last verified: January 2008
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Cordarone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Prism Pharmaceuticals:

Primary Outcome Measures:
  • Relative bioavailability and safety

Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420953

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

No publications provided

ClinicalTrials.gov Identifier: NCT00420953     History of Changes
Other Study ID Numbers: 101
Study First Received: January 8, 2007
Last Updated: January 14, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on July 23, 2014