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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: verapamil controlled release

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence	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.	72 hours

Collaborators and Investigators

• Sponsor: Synerx Pharma, LLC
• Investigators: Principal Investigator: Gaetano Morelli, MD, MDS Pharma

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2011
• Last Update Submitted That Met QC Criteria: November 8, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Verapamil
• Other Study ID Numbers: AA32724