Clinical trial: Lovastatin and Its ß-hydroxy Acid From Four 600 mg LipoCol Forte® Capsules Compared to That of One 20 mg Mevacor® Tablet in Healthy Subjects (NCT01346670)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects must be at the age of 20-40 years old and in good health on the basis of
             medical history, physical examination, electrocardiogram, chest X-ray, and routine
             laboratory evaluations.

          2. Vital signs (after 3 minutes resting in a upright position) which are within the
             following ranges:Ear body temperature between 35.0-37.5 degree celsius (°C). Systolic
             blood pressure, 90-140 millimeters of mercury (mm Hg). Diastolic blood pressure, 50-90
             millimeters of mercury (mm Hg). Pulse rate, 50-90 beats per minute (bpm). Fasting
             blood glucose, < 110 milligrams per deciliter (mg/dL).

          3. Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body
             weight.

          4. Able to sign informed consent prior to study.

          5. Able to communicate well with the investigator and comply with the requirements of the
             study.

        Exclusion Criteria:

          1. Use of any prescription medication within 14 days prior to dosing.

          2. Use of over-the-counter medications or vitamins within 14 days prior to dosing.

          3. Significant illness within 2 weeks prior to dosing.

          4. Participation in any clinical investigation within 2 months prior to dosing or longer
             than required by local regulation.

          5. Donate or loss more than 500 milliliter (mL) of blood within 3 months prior to dosing.

          6. Presence of cardiovascular disease.

          7. Presence of gastrointestinal disease.

          8. Presence of asthma or lung disease.

          9. Presence of liver disease or liver injury as indicated by an abnormal liver function
             profile.

         10. Presence of impaired renal function.

         11. Presence of neurological disease.

         12. Presence of psychiatrical disease.

         13. A known hypersensitivity to lovastatin and Chinese Red Yeast Rice or their analogs.

         14. History of drug or alcohol abuse within 12 months prior to dosing.

         15. Permanent confinement to an institution.

         16. Pregnant or lactating women.

         17. Individuals are judged by the investigator or co-investigator to be undesirable as
             subjects for other reasons.
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 40 Years

Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? 0