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Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions

NCT ID: NCT00775905

Last Updated: 2008-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-10-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Healthy

Keywords

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Bioequivalence amlodipine tablets fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

amlodipine 10 mg tablets of Ranbaxy

Group Type EXPERIMENTAL

amlodipine 10 mg tablet

Intervention Type DRUG

2

Norvasc® 10 mg tablets

Group Type ACTIVE_COMPARATOR

amlodipine 10 mg tablet

Intervention Type DRUG

Interventions

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amlodipine 10 mg tablet

Intervention Type DRUG

Eligibility Criteria

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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)?
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ranbaxy Laboratories Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Ranbaxy Research Laboratories

Locations

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SFBC Ft. Myers, Inc.

Fort Myers, Florida, United States

Site Status

Countries

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United States

Related Links

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http://clinicalstudies.ranbaxy.com.

Related Info

http://www.fda.gov/opacom/7alerts.html

Related Info

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Related Info

Other Identifiers

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50365

Identifier Type: -

Identifier Source: org_study_id