- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00946621
To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions
March 27, 2017 updated by: Sandoz
A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions
To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under non-fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Ramipril 10 mg Capsule (Sandoz)
|
|
Active Comparator: 2
Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on AUC and Cmax
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
November 1, 2004
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
July 24, 2009
First Submitted That Met QC Criteria
July 24, 2009
First Posted (Estimate)
July 27, 2009
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B043724
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Ramipril 10 mg Capsule (Sandoz)
-
SandozCompleted
-
Teva Pharmaceuticals USACompleted
-
Teva Pharmaceuticals USACompleted
-
Teva Pharmaceuticals USACompleted
-
Vedic Lifesciences Pvt. Ltd.Not yet recruitingUpper Respiratory Tract InfectionsIndia
-
Natrogen Therapeutics International, IncUnknownUlcerative ColitisUnited States
-
AstraZenecaCompletedZollinger-Ellison Syndrome | Reflux Esophagitis (RE) | Gastric Ulcer (GU) | Duodenal Ulcer (DU) | Anastomotic Ulcer (AU) | Non-erosive Reflux Esophagitis Disease (NERD)Japan
-
SandozCompleted
-
SandozCompleted
-
University of California, San DiegoPfizerCompleted