Clinical trial: Evaluation of the Food Effect on the Safety, Tolerability, PK of EC-18 After Oral Administration in Healthy Volunteers (NCT02700360)

Eligibility criteria:
Inclusion Criteria:

          1. Healthy adult aged between 19 and 45 years, inclusive, at the time of providing the
             informed consent form

          2. body weight: ≥ 55kg(male), ≥ 50kg(female)

          3. BMI: 18.5 kg/m2 ≦ BMI < 25.0 kg/m2 [BMI(body mass index) = Body weight (kg)/[height
             (m)]2 ]

          4. in female subjects, the result of serum β-hCG pregnancy test comes out negative at
             screening, urine β-hCG test comes out negative before taking medication during the
             period set by this protocol have to be included one of the below conditions.

               -  postmenopausal(no natural menstruation at least 2 years)

               -  surgically sterile(hysterectomy or bilateral ovariotomy, tubal ligation or
                  sterile condition by other ways)

               -  sterility of male partner before screening(proof the azoospermia after
                  vasectomy), and this is the only partner of the subject.

               -  agree with using a proper and continuous method of contraception start on 14
                  days(at least) before the1st IND administration and for 28 days(at least) after
                  the last IND administration

                    -  proper contraception means physical barrier method including condom,
                       contraceptive diaphragm or cervix cap, do not use a hormones including
                       contraceptive or oral contraceptive during the study.

          5. if the male have a sex life with childbearing aged female, maintain proper
             contraception during the study and for 28 days after the last IND administration,
             agree with "do not donate the sperm"(if the female partner is infertility, above
             contraceptions are not necessary)

          6. Written consent on voluntary decision of participation and compliance with precautions
             after being fully informed of and completely understanding this trial

        Exclusion Criteria:

          1. Hypersensitivity to a drug containing an ingredient of the investigational
             product(EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g.,
             aspirin, antibiotics) or medical history of clinically significant hypersensitivity

          2. Active infection such as chronic or local infection based on screening tests or
             inquiry, verifiable medical records

          3. Serious infection that required hospitalization or use of antibiotics within 30 days
             prior to the first dose of the investigational product, based on an inquiry or
             verifiable medical records

          4. Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory,
             musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric
             disorder or its prior history

          5. (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results
             from a QuantiFERON®-TB Gold in Tube Assay conducted due to a contact with a
             tuberculosis patient within the past 3 months or signs and symptoms of suspected
             tuberculosis

          6. Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery
             (except for simple appendectomy or hernia surgery) that may affect drug absorption,
             etc.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment