Healthy
Conditions
Keywords
Bioequivalence, Ramipril, Healthy subjects
Brief summary
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.
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
Interventions
A: Experimental Subjects received Purepac formulated products under fed conditions
B: Active comparator Subjects received Monarch Pharmaceuticals Inc. formulated products under fed conditions
Sponsors
Actavis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate and Extend of Absorption | 96 hours |
Countries
United States
Outcome results
None listed