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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00775905 |
The objective of this study was to compare the rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in fasted subjects.
Condition | Intervention |
---|---|
Healthy |
Drug: amlodipine 10 mg tablet |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | The Objective of This Study Was to Compare the Rate and Extent of Absorption of Ranbaxy Amlodipine 10 mg Tablet to That of Norvasc® 10 mg Tablet After a Single, One Tablet Dose in Fasted Subjects. |
Enrollment: | 40 |
Study Start Date: | July 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
amlodipine 10 mg tablets of Ranbaxy
|
Drug: amlodipine 10 mg tablet |
2: Active Comparator
Norvasc® 10 mg tablets
|
Drug: amlodipine 10 mg tablet |
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Amlodipine besylate formulations comparing Amlodipine 10mg tablets of Ranbaxy Laboratories with (Norvasc®, Pfizer Inc USA, in healthy, adult, human, subjects under fasting conditions
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A no answer to any of the above questions indicated that the individual was ineligible for enrollment
Exclusion Criteria:
Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
Responsible Party: | Ranbaxy Research Laboratories ( Tausif Monif ) |
Study ID Numbers: | 50365 |
Study First Received: | October 16, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00775905 |
Health Authority: | United States: Institutional Review Board |
Bioequivalence amlodipine tablets fasting |
Calcium, Dietary Healthy Amlodipine |
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