Clinical trial: A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device (NCT02060929)

Eligibility criteria:
Inclusion Criteria:

          -  Agrees to protocol-defined use of effective contraception

          -  If a woman, must have a negative serum human chorionic gonadotropin (hCG) pregnancy
             test at screening; and a negative urine pregnancy test on Day -1 of each treatment
             period

          -  Body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive),
             and body weight not less than 50 kg

          -  Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg
             systolic, inclusive, and no higher than 90 mmHg diastolic

          -  A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and
             function

        Exclusion Criteria:

          -  Current or prior history of psychiatric disorder including but not limited to
             psychotic, bipolar, major depressive, or anxiety disorder

          -  Clinically significant medical illness including cardiac arrhythmias or other cardiac
             disease, hematologic disease, coagulation disorders , lipid abnormalities, significant
             pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus,
             renal or hepatic insufficiency, thyroid disease, neurologic disease, infection,
             hypertension or vascular disorders, kidney or urinary tract disturbances, sleep apnea,
             myasthenia gravis, or any other illness

          -  Clinically significant abnormal values for hematology, clinical chemistry, or
             urinalysis at screening or at admission to the study center (Day -1) as deemed
             appropriate by the investigator

          -  Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at
             screening or at admission to the study center (Day -1 of each treatment period) as
             deemed appropriate by the investigator

          -  Has an abnormal or deviated nasal septum with any 1 or more of the following symptoms:
             blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent
             nosebleeds, frequent sinus infections, noisy breathing during sleep, facial pain,
             headaches, and postnasal drip
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 55 Years

Patient description (medical language): A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years.

Patient description (patient's own words): I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL.

Does the patient match the trial criteria? Contradiction