A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fed Conditions

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Ramipril10 mg Capsules Under Fed Conditions

To compare the rate of absorption and oral bioavailability of a test formulation of Ramipril10 mg Capsules manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product Atlace® manufactured by Monarch Pharmaceuticals Inc. administrated to healthy subjects after a 10-hour overnight fast followed by a high-calorie, high-fat breakfast meal.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ramipril10 mg Capsules, single dose; Drug: Atlace® 10 mg capsules, single dose

Detailed Description

Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period crossover study

Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Ramipril10 mg Capsules Under Fed Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78759
      • CEDRA Clinical Research, LLC

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:

• Subject must be a male or non-pregnant, non-breast-feeding female.
• Subject must be between 18 and 55 years of age inclusive.
• Subject's body weight should be within ±15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table.
• Female subjects of childbearing potential --- not surgically sterile or at least two years postmenopausal-- must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
• Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
• Subject is willing and able to remain in the research center for the entire duration of each confinement period and return to the research center for any outpatient visits.

Exclusion Criteria:

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
• Has a clinically significant abnormal finding on the physical exam, medical history or clinical laboratory results at screening.
• History or presence of allergic or adverse response to the study drug or related drugs.
• Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
• Has donated blood or plasma within 30 days prior to the first dose of study medication.
• Has participated in another clinical trial within 30 days prior to first dose of study medication.
• Has used any over-the-counter (OTC) medication including vitamins, within 7 days prior to the first dose of study medication.
• Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 7 days prior to the first dose of study medication.
• Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
• Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
• Has a history of substance abuse (including alcohol) in the past 5 years
• Is female with a positive pregnancy test.
• Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
• Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Ramipril10 mg Capsules, single dose	Drug: Ramipril10 mg Capsules, single dose; A: Experimental Subjects received Purepac formulated products under fed conditions; Other Names: Ramipril
ACTIVE_COMPARATOR: B; Atlace® 10 mg capsules, single dose	Drug: Atlace® 10 mg capsules, single dose; B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products under fed conditions; Other Names: Ramipril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	96 hours

Collaborators and Investigators

• Sponsor: Actavis Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (ACTUAL): October 1, 2004
• Study Completion (ACTUAL): October 1, 2004

Study Registration Dates

• First Submitted: March 17, 2009
• First Submitted That Met QC Criteria: March 17, 2009
• First Posted (ESTIMATE): March 18, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 16, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy subjects; Ramipril
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Ramipril
• Other Study ID Numbers: 20-678-1G