Clinical trial: Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions (NCT01506791)

Eligibility criteria:
Inclusion Criteria:

          -  Is the individual a healthy, normal adult man or woman who volunteers to participate?

          -  Is s/he within 18 to 45 years of age, inclusive?

          -  Is his/her BMI between 19 and 30 inclusive?

          -  Is she willing to avoid pregnancy by abstaining from sexual intercourse with a
             non-sterile male partner, or by the use one of the following methods: diaphragm +
             spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine
             contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or
             has she been surgically sterile or post-menopausal at least six months prior to
             entering into the study?

          -  Is s/he considered reliable and capable of understanding his/her responsibility and
             role in the study?

          -  Has s/he provided written informed consent?

        Exclusion Criteria:

          -  Does the individual have a history or allergy or hypersensitivity to desloratadine or
             pseudoephedrine, milk or eggs?

          -  Does s/he have clinically significant laboratory abnormalities that would interfere
             with the conduct or interpretation of the study or jeopardize his/her safety?

          -  Does s/he have significant history or clinical evidence of auto-immune,
             cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological,
             ongoing infection, pancreatic, or renal disease that would interfere with the conduct
             or interpretation of the study or jeopardize his/her safety?

          -  Is she nursing?

          -  Does s/he have serious psychological illness?

          -  Does s/he have significant history (within the past year) or clinical evidence of
             alcohol or drug abuse?

          -  Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C
             screen, or a positive pregnancy test?

          -  Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or
             beverages during periods beginning 48 hours prior to study drug administration and
             ending when the last blood sample has been taken in each study period?

          -  Has s/he used any prescription drug, other than hormonal contraceptives, during the 14
             day period prior to study initiation, or any OTC drug during the 72 hour period
             preceding study initiation?

          -  Is s/he unable to refrain from the use of all concomitant medications, other than
             hormonal contraceptives, during the study?

          -  Has s/he donated or lost blood or participated in a clinical study which involved the
             withdrawal of a large volume of blood (480 mL or more), during the six week period
             preceding study initiation?

          -  Has s/he donated plasma during the two week period preceding study initiation?

          -  Has s/he received an investigational drug during the 30 day period preceding study
             initiated?

          -  Has s/he used any tobacco products in the 3 months preceding drug administration?
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 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