Clinical trial: Rosuvastatin Calcium Bioequivalence Study - Fast (NCT01711749)

Eligibility criteria:
Inclusion Criteria:

          -  Man or woman aged between 18 to 50 years. Women can not be pregnant nor breastfeeding,
             and man and woman commit to use an efficient contraceptive method along the entire
             study period;

          -  Volunteers of Asian descent, due to differences in the pharmacokinetics of
             rosuvastatin in this group of people;

          -  Volunteers cholecystectomy;

          -  Female subjects of childbearing potential must not become pregnant during the study
             period, thus, should be sexually inactive through abstinence or use of contraceptive
             methods the failure rate <1%. Inactivity sexual abstinence should be consistent with
             the usual lifestyle of the subject. Periodic abstinence and withdrawal are not
             acceptable methods of contraception. Will be accepted as methods of contraception with
             failure rate less than 1%: oral contraceptives, either combined or progestogen alone,
             injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring,
             Percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system
             (IUS ) that meets the failure rate <1%, double barrier method, partner sterilization
             (vasectomy with documentation of azoospermia) prior to the female subject's entry into
             the study, and this male is the sole partner for that subject;

          -  Body mass index ≥ 18.5 or ≤ 29.9 kg/m²;

          -  Volunteers with good health conditions and without significant diseases at medical
             criterion, as per the Clinical History; Blood pressure, pulse and temperature are
             taken, Physical examination, ECG and complementary Lab examinations;

          -  The volunteer is healthy as determined by a responsible and experienced physician,
             based on a medical evaluation including medical history, physical examination,
             laboratory tests and cardiac monitoring. A subject with a clinical abnormality or
             laboratory parameters outside the reference range for the population being studied may
             be included only if the Investigator and the Medical Monitor agree that the finding is
             unlikely to introduce additional risk factors and will not interfere with the study;

          -  The volunteer must be able to understand nature and purpose of the study, including
             the risks and adverse effects and must show good intention to cooperate with the
             researcher and act according to the requirement of the entire trial, what is confirmed
             by the signature of an Informed Consent.

        Exclusion Criteria:

          -  The volunteer has a known hypersensitivity to the drug being studied or to any
             chemically related compounds;

          -  History or existence of hepatic or GI diseases or any other condition that could
             interfere with the absorption, distribution, excretion or metabolism of the drug;

          -  Use of maintenance therapy with any drug but oral contraceptives;

          -  History of hepatic, renal, pulmonary, GI, neurological, hematological, psychiatric,
             cardiologic or allergic problem of any etiology that needs drug treatment or that the
             researcher considers it is clinically relevant;

          -  Current or chronic history of liver disease, or know hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstone);

          -  ECG findings, not recommended at the researcher's criterion to participate in the
             study;

          -  Results of complementary lab tests that are out of the values considered normal,
             according to this protocol guidelines, unless the researcher considers them
             non-clinically significant;

          -  Smoke abuse;

          -  Daily ingestion of more than five cups of coffee;

          -  History of alcohol or drug abuse;

          -  Use of regular medication along the two weeks that preceded the study commencement, or
             use of any other medication one week before the study commencement;

          -  Hospitalization for any reason up to 8 weeks before the first period of study;

          -  Treatment along three months before the treatment commencement of the study with any
             drug known because of its well-defined toxic potential to major organs;

          -  Participation in any pharmacokinetics study with collection of more than 300 mL of
             blood or ingestion of any experimental drug along six months before the treatment
             commencement of the study;

          -  Donation or loss of ≥ 450 mL of blood along the three months that preceded the study
             or donation of more than 1500 mL along the 12 months before the treatment commencement
             of the study;

          -  Positive result for βHCG in urine in female volunteer;

          -  A positive pre-study Hepatitis B surface antigen or positive Hepatites C antibody
             result within 3 months os screening;

          -  Female subjects not using a contraceptive method that meets the failure rate <1%;

          -  Any condition that prevents the participation in the study, according to the
             researcher's judgment.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction