- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00775151
Bioequivalence Study of Amlodipine 10mg Tablets Under Fed Conditions
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 Fed State Subjects.
Study Overview
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 fed conditions
Enrolled and randomized: 40 each treatment) Drop-outs (withdrew from study): 1 Withdrawals (was dropped from study): 4 Completed: 36
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Fort Myers, Florida, United States, 33901
- SFBC Ft. Myers, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)?
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Norvasc® 10 mg tablets
|
|
Experimental: 1
amlodipine 10 mg tablet of Ranbaxy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Bioequivalence
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50366
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.
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