Back to resultsBioequivalency Study of Amlodipine Tablets Under Fed Conditions
Primary Purpose
Hypertension, Chronic Stable Angina, Vasospastic Angina
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion Criteria:
- Positive test for HIV, Hepatitis B, or Hepatitis C.
- Treatment with known enzyme altering drugs.
- History of allergic or adverse response to Amlodipine Besylate or any comparable or similar product.
Sites / Locations
- Gateway Medical Research, Inc.
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00601302
Brief Title
Bioequivalency Study of Amlodipine Tablets Under Fed Conditions
Official Title
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Chronic Stable Angina, Vasospastic Angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, Two period, Twenty-one day washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
Exclusion Criteria:
Positive test for HIV, Hepatitis B, or Hepatitis C.
Treatment with known enzyme altering drugs.
History of allergic or adverse response to Amlodipine Besylate or any comparable or similar product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Parham, MD
Organizational Affiliation
Cetero Research, San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway Medical Research, Inc.
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Amlodipine Tablets Under Fed Conditions
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