Clinical trial: Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine (NCT01842230)

Eligibility criteria:
Inclusion Criteria:

          1. Between 20 aged and 45 aged in healthy male and female

          2. Body weight more than 55kg in male, 50kg in female

          3. Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2) 4.If
             female, must include more than one among the items

               1. The menopause (there is no natural menses for at least 2 years)

               2. Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or
                  other methods of infertility condition)

               3. The male partner infertility before screening (Demonstrated azoospermia after
                  vasectomy)and if this man is the only partner of the female subject.

               4. you are using one of the following contraceptive measure for 3 months before
                  screening, and Necessarily you agree that used continuously contraceptive measure
                  during the clinical trial and for 1 month after the final dosing investigational
                  product.(But, should not use a device of contraception or oral contraceptive drug
                  that containing a hormonal caused telmisartan, s-amlodipine, atorvastatin calcium
                  drug interactions during the clinical trials)

                    -  Abstinence.

                    -  Physical interrupt method (such as a condom, contraceptive diaphoretic or
                       cervical cap)

               5. In case of women of childbearing age, the serum β-hCG pregnancy test is negative,
                  and urine β-hCG test is negative before taking the investigational product.

        5.If men has sexual life with women of childbearing age, Necessarily he agrees that use
        condoms during clinical trials and do not sperm donation during clinical trials and until
        one month after the final dosage of investigational products 6.Those who fully understand
        about this clinical trial after enough hearing, and then decided to join the clinical
        trials by themselves and to comply with the precautions written consent.

        Exclusion Criteria:

          1. Have clinically significant disease that hepatobiliary system(severe hepatic
             impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune
             system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular
             system (heart failure, etc.).or mental illness, or a history of mental disease.

          2. Have a gastrointestinal disease history that can affect drug absorption (Crohn's
             disease, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery)

          3. hypersensitivity reaction to drug or clinically significant hypersensitivity reaction
             in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin
             calcium) or additives.

          4. An impossible one who participates in clinical trial including screening tests(medical
             history taking, BP, physical examination, 12-lead ECG, blood & urine laboratory test
             result) before 28 days the taking Investigational Products.

          5. Defined by the following laboratory parameters:

               1. AST, ALT> 1.25* upper limit of normal range

               2. Total bilirubin > 1.5* upper limit of normal range

               3. CPK > 1.5* upper limit of normal range

               4. eGFR(using by MDRD method) < 60 mL/min/1.73m2

          6. Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after
             5minuts break.

          7. Drug abuse or have a history of drug abuse showed a positive for urine drug test.

          8. Pregnant or lactating women.

          9. A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or
             smoker(cigarette>10cigarettes/day)

         10. Subject takes ethical drug or herbal medicine within 14days, OTC within 7days before
             the beginning of study treatment but investigator determine that the taking drug
             affect this study or could affect the safety of the subjects.

         11. Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates
             etc.) within 30 days.

         12. Taking foods containing grapefruit within 7 days before the beginning of study
             treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days
             before the beginning of study treatment)

         13. Subject who treated with any investigational drugs within 60days before the beginning
             of study treatment (However, biologicals applies for 90 days, but can be based on a
             more extended period of time by considering the half-life)

         14. Previously donate whole blood within 60 days or component blood within 30days.

         15. An impossible one who participants in clinical trial by investigator's decision
             including laboratory test result or another reason.

         16. Positive for Serology test(Hepatitis B, Hepatitis C, HIV).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction