Bioequivalence Study of Amlodipine 10mg Tablets Under Fed Conditions

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Amlodipine

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)?