Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions
Bioequivalence Study of Amlodipine Tablets Under Fasting 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, one4ablet dose in
 fasted subjects.
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
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)?