Clinical trial: Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin (NCT03807050)

Eligibility criteria:
Inclusion Criteria:

          1. Healthy male volunteers between 18 and <46 years of age.

          2. Subjects who provide written informed consent to participate in the study.

          3. BMI ranging from 18.0 to <30.0, calculated as Weight (Kg)/Height (m2).

          4. Non-smoking (by declaration) for a period of at least 6 months.

          5. No known history of significant neurological, renal, cardiovascular (including known
             structural cardiac abnormalities or hypertension), respiratory (asthma), endocrine,
             gastrointestinal, hepatic or hematopoietic disease, neoplasm, psychiatric or any other
             clinically significant medical disorder, which in the investigator's judgment
             contraindicate administration of the study medications.

          6. No history of drug or alcohol abuse.

          7. No known allergy or hypersensitivity to any drug or food.

          8. No clinically significant abnormalities in screening physical exam.

          9. No clinically significant abnormalities in clinical laboratory parameters (hematology,
             biochemistry and urinalysis) at Screening, as determined by the study physicians.

         10. Negative HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody tests at
             Screening.

         11. No significant abnormalities in electrocardiogram.at Screening.

         12. Subjects with negative urinary drugs of abuse screen determined at Screening and on
             admission to the clinical research center prior to dosing day.

         13. Subjects must be able to adhere to the visit schedule and protocol requirements and be
             available to complete the study.

         14. Subjects must satisfy a medical examiner about their fitness to participate in the
             study.

        Exclusion Criteria:

          1. Subjects with any clinically significant abnormality upon physical examination or in
             the clinical laboratory test values.

          2. Subjects with a history of clinically defined peptic ulcer or any gastrointestinal
             surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder
             likely to influence supplement absorption, or with any history of severe
             gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.

          3. Subjects with significant allergic response to any drug or history of food allergies
             deemed clinically significant or exclusionary for the study.

          4. Adherence (for whatever reason) to an abnormal diet during the 4 weeks prior to the
             study, or subjects with recent significant change in body weight.

          5. Treatment with prescription or over-the-counter drugs, nutraceuticals including
             vitamins, herbal medications, food supplements and other prescription drugs not
             mentioned above, within 7 days prior to first dosing day.

          6. Use of paracetamol (acetaminophen) less than 24 hours before the first dosing day.

          7. Subjects who donated blood or received blood or plasma derivatives in the three months
             preceding the first study dosing.

          8. Participation in another clinical trial with drugs within 3 months prior to first
             study dosing day (calculated from the previous study's last dosing date).

          9. Subjects with an inability to communicate well with the investigators and Clinical
             research Center staff (i.e., language problem, poor mental development or impaired
             cerebral function).

         10. Subjects that have difficulty fasting or consuming the standard meals that will be
             provided.

         11. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of
             study start, which is considered of significance by the Principal Investigator.

         12. Subjects who are non-cooperative or unwilling to sign the consent form.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 46 Years

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? Entailment