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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01467687

Enrollment

Registered

2011-11-09

Start date

2007-07-31

Completion date

2007-08-31

Last updated

2011-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

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.

Interventions

DRUGverapamil controlled release

verapamil 300 mg controlled release capsule as a single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Bioequivalence	72 hours	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026