Comparative Bioavailability Study of Synerx and Verelan PM 300 mg Verapamil HCl ER Capsules Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synerx Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01467687
First received: October 31, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to determine the bioequivalency of Synerx Pharma Verapamil extended release capsules.


Condition Intervention Phase
Healthy
Drug: verapamil controlled release
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Synerx Pharma and Verelan PM 300 mg Verapamil HCl Extended Release Capsules Controlled-Onset in Healthy Aduly Volunteers Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Synerx Pharma, LLC:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Statistical comparison of verapamil blood levels obtained over 72 hours when dosed with either the Verelan PM capsule or Synerx Pharma verapamil controlled release capsule. The comparison will compare Cmax and AUC and provide 80 to 125% confidence intervals for the values.


Enrollment: 58
Study Start Date: July 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
300 mg capsule of Verelan PM or 300 mg verapamil controlled release capsule given orally with food as a single dose with blood collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 30, 36, 48, 60 and 72 hours.
Drug: verapamil controlled release
verapamil 300 mg controlled release capsule as a single dose
Other Names:
  • Verelan PM
  • verapamil controlled release capsule
Active Comparator: 2
300 mg capsule of Verelan PM or 300 mg verapamil controlled release capsule given orally with food as a single dose with blood collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 30, 36, 48, 60 and 72 hours.
Drug: verapamil controlled release
verapamil 300 mg controlled release capsule as a single dose
Other Names:
  • Verelan PM
  • verapamil controlled release capsule

Detailed Description:

The purpose of this study is to determine if Synerx Pharma Verapamil HCl ER Capsules are bioequivalent to Verelan PM capsules in healthy volunteers under food effect conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy adult male or female volunteers, 18-55 years of age. Subjects will be continuous non-smokers for at least 3 months prior to the first dose.

Weighing at least 60 kg for males and 52 kg for females and within the normal range according to accepted normal values of the Body Mass Index Chart (18.00 -28.00 kg/m2).

Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.

Absence of any exclusion criteria during history, physical, or laboratory evaluation.

Confirmation that all female subjects are not pregnant by a certified, validated pregnancy test.

Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be an acceptable birth control method Postmenopausal women with amenorrhea for at least 2 years will be eligible. Give voluntary written informed consent to participate in the study.

Exclusion Criteria:

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.

In addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to verapamil, other calcium ion influx inhibitors or any other component of the product formulations; idiosyncratic reaction to acetaminophen; malabsorption within the past year; recurrent headaches or migraines. Presence of a medical condition requiring regular treatment with prescription drugs.

Tests giving reasonable suspicion of a disease that would contraindicate taking an investigational drug or that might affect the interpretation of the results of the study.

Female subjects who are pregnant or lactating. Subjects who tested positive at screening for HIV, HbsAg or HCV. Positive test results for drugs of abuse or alcohol. Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg prior to dosing in each period.

Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing in each period.

Subjects whose PR interval is >190 msec at screening and >200 msec prior to dosing in each period.

Subjects whose QTc interval is >450 msec at screening and prior to dosing in each period.

Subjects who have used any drugs or substances known to be strong inducers and/or inhibitors of CYP enzymes within 28 days prior to the first dose.

Subjects who have been on a special diet during the 28 days prior to the first dose and throughout the study.

Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to the first dose.

  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: NCT01467687

Sponsors and Collaborators
Synerx Pharma, LLC
Investigators
Principal Investigator: Gaetano Morelli, MD MDS Pharma
  More Information

No publications provided

Responsible Party: Synerx Pharma, LLC
ClinicalTrials.gov Identifier: NCT01467687     History of Changes
Other Study ID Numbers: AA32724
Study First Received: October 31, 2011
Last Updated: November 8, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Verapamil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on October 19, 2014