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Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00775905
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : October 20, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: amlodipine 10 mg tablet Not Applicable

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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.
Study Start Date : July 2005
Actual Primary Completion Date : August 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
amlodipine 10 mg tablets of Ranbaxy
Drug: amlodipine 10 mg tablet
Active Comparator: 2
Norvasc® 10 mg tablets
Drug: amlodipine 10 mg tablet



Primary Outcome Measures :
  1. Bioequivalence


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra- uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy?
  • Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study.
  • Has s/he provided written informed consent?

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?

    • Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'?
    • Is she nursing?
    • Does s/he have serious psychological illness?
    • Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? •
    • Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation?
    • Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?
    • Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
    • Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
    • Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?

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)?


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775905


Locations
United States, Florida
SFBC Ft. Myers, Inc.
Fort Myers,, Florida, United States, 33901
Sponsors and Collaborators
Ranbaxy Laboratories Limited

Additional Information:
Responsible Party: Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00775905     History of Changes
Other Study ID Numbers: 50365
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: October 2008

Keywords provided by Ranbaxy Inc.:
Bioequivalence amlodipine tablets fasting

Additional relevant MeSH terms:
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents