Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00775905
First received: October 16, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

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
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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)?

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775905

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

Additional Information:
No publications provided

Responsible Party: Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00775905     History of Changes
Other Study ID Numbers: 50365
Study First Received: October 16, 2008
Last Updated: October 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalence amlodipine tablets fasting

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

ClinicalTrials.gov processed this record on April 17, 2014