Clinical trial: Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) (NCT03173742)

Eligibility criteria:
Inclusion Criteria:

          1. Caucasian subjects of either gender (male or female) with an age between 18 and 45
             years (both inclusive).

          2. Medical history and physical examination with no relevant abnormal findings.

          3. No evidence of significant disease (organic or psychiatric) based on medical history,
             physical examination and complementary tests.

          4. Laboratory tests (complete hematology, clinical chemistry and urinalysis).

          5. Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and
             electrocardiogram (ECG) record within normal range at screening.

          6. Participating female volunteers must use a reliable contraception method not
             containing hormones. List of accepted contraception method includes barrier methods
             (i.e. female/male condoms, diaphragms, spermicides), voluntary sterilization (female
             tubal occlusion) or non-medicated intrauterine devices (IUD) (i.e. inert or
             copper-releasing). Abstention is not considered a reliable contraception method.

          7. For female volunteers only: they must declare that they did not intend to become
             pregnant in the last month prior to screening and they do not intend to become
             pregnant during one month following the last study drug administration.

          8. Voluntary participation in the study, with written informed consent from the
             volunteer.

          9. The subject agrees to abstain from beverages or food containing methylxanthines
             (coffee, tea, cola, energy drinks, chocolate etc.), St John's Wort, vitamins, herbal
             remedies and chewing-gum for 48 hours prior to study drug administration and during
             each study period.

         10. The subject agrees to abstain from beverages or food containing grapefruit for 14 days
             prior to the first study drug administration and during the study (until last sample
             from the last period).

        Exclusion Criteria:

          1. Background of allergy, idiosyncrasy or hypersensitivity to the study drugs or its
             excipients.

          2. Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks
             per day).

          3. Background of alcoholism or drug dependence in the last one year or daily consumption
             of alcohol > 40 gr/day for men or > 24 gr/day for women.

          4. Use of any medication within 15 days prior to taking the study treatment, including
             over-the-counter medications and medicinal plants (except for the use of paracetamol
             in short-term symptomatic treatments).

          5. Positive serology for hepatitis B, C or HIV.

          6. Background or clinical evidence of cardiovascular, respiratory, renal, hepatic,
             endocrine, gastrointestinal, hematological or neurological disease or other chronic
             diseases.

          7. Smokers or ex-smokers that gave up smoking less than 1 year prior to the study (day 1
             of period I)

          8. Pregnancy or lactation status for female subjects.

          9. Participation in another clinical trial during the 3 months before starting the
             current trial.

         10. Donate blood in the 8 weeks prior to starting the study.

         11. Undergone major surgery during the previous 6 months.

         12. Clinically significant abnormal ECG with clinical significance in accordance with the
             CIM's clinical criterion

         13. Restrictive vegetarian diet

         14. Positive results to the breath alcohol test at screening or at Day -1

         15. Positive results to the drug abuse checks (urine test for: amphetamines, cannabinoids,
             opiates, benzodiazepines and cocaine) at screening or at admission on Day -1

         16. Epidemiological risk of being infected by Loa loa or other filariases, defined as
             those who have lived or have travelled to any of the following countries: Angola,
             Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo,
             Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan.
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 45 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction