Overview

A Relative Bioavailability Study of Ramipril 10 mg Capsules Administered Orally as a Sprinkle on Applesauce

Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
0
Participant gender:
All
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 as a sprinkle on one tablespoonful of applesauce to healthy subjects after a 10-hour overnight fast
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Actavis Inc.
Treatments:
Ramipril
Criteria
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.