Clinical trial: Bioequivalence Study of Amlodipine 10mg Tablets Under Fed Conditions (NCT00775151)

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)?
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? 1