bioequivalence study of amlodipine 10mg tablets under fed conditions

Conditions: Healthy

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, one tablet dose in fed state 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 fed conditions enrolled and randomized: 40 each treatment) drop-outs (withdrew from study): 1 withdrawals (was dropped from study): 4 completed: 36

Eligibility 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)?

Keywords: bioequivalence amlodipine 10 mg tablet under fed conditions