Clinical trial: Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects (NCT02322671)

Eligibility criteria:
Inclusion Criteria:

          -  Male and females aged between 18 and 65 years of age inclusive, at the time of signing
             the informed consent.

          -  Healthy as determined by the investigator or medically qualified designee based on a
             medical evaluation including medical history, physical examination, laboratory tests
             and cardiac monitoring.

          -  A subject with a clinical abnormality or laboratory parameter(s) which is/are not
             specifically listed in the inclusion or exclusion criteria, outside the reference
             range for the population being studied may be included only if the investigator in
             consultation with the Medical Monitor if required, agree and document that the finding
             is unlikely to introduce additional risk factors and will not interfere with the study
             procedures.

          -  Body weight >= 50 kilograms (kg) and Body mass index (BMI) within the range 19 - 24.9
             kilograms per square meter (kg/m^2) (inclusive).

          -  Male subject

          -  Female subject: is eligible to participate if she is not pregnant (as confirmed by a
             negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least
             one of the following conditions applies:

        Non-reproductive potential defined as:

        Pre-menopausal females with one of the following:

        Documented tubal ligation Documented hysteroscopic tubal occlusion procedure with follow-up
        confirmation of bilateral tubal occlusion Hysterectomy Documented Bilateral Oophorectomy

          -  Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a
             blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels
             consistent with menopause (refer to laboratory reference ranges for confirmatory
             levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is
             in doubt will be required to use one of the highly effective contraception methods if
             they wish to continue their HRT during the study. Otherwise, they must discontinue HRT
             to allow confirmation of post-menopausal status prior to study enrolment.

          -  Reproductive potential and agrees to follow one of the options listed below in the
             GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy
             in Females of Reproductive Potential (FRP) requirements from 30 days prior to the
             first dose of study medication and until [at least five terminal half-lives OR until
             any continuing pharmacologic effect has ended, whichever is longer] after the last
             dose of study medication and completion of the follow-up visit.

        GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP This list does
        not apply to FRP with same sex partners, when this is their preferred and usual lifestyle
        or for subjects who are and will continue to be abstinent from penile-vaginal intercourse
        on a long term and persistent basis.

          -  Contraceptive subdermal implant that meets the standard operating procedure
             (SOP)effectiveness criteria including a <1% rate of failure per year, as stated in the
             product label

          -  Intrauterine device or intrauterine system that meets the SOP effectiveness criteria
             including a <1% rate of failure per year, as stated in the product label

          -  Oral Contraceptive, either combined or progestogen alone

          -  Injectable progestogen

          -  Contraceptive vaginal ring

          -  Percutaneous contraceptive patches

          -  Male partner sterilisation with documentation of azoospermia prior to the female
             subject's entry into the study, and this male is the sole partner for that subject

          -  Male condom combined with a vaginal spermicide (foam, gel, film, cream, or
             suppository) only for the following 3 situations when there is a very low risk for
             developmental toxicity: Vaccines; Monoclonal antibodies when there is no target
             biology concern; Compounds that have a complete reproductive toxicology package and
             have not shown any signal for developmental toxicity.

        These allowed methods of contraception are only effective when used consistently, correctly
        and in accordance with the product label. The investigator is responsible for ensuring that
        subjects understand how to properly use these methods of contraception.

          -  Male subjects with female partners of child bearing potential must comply with the
             following contraception requirements from the time of first dose of study medication
             until [at least five half-lives of study medication or for a cycle of spermatogenesis
             following five terminal half-lives] after the last dose of study medication.

          -  Vasectomy with documentation of azoospermia.

          -  Male condom plus partner use of one of the contraceptive options below:

          -  Contraceptive subdermal implant that meets the SOP effectiveness criteria including a
             <1% rate of failure per year, as stated in the product label

          -  Intrauterine device or intrauterine system that meets the SOP effectiveness criteria
             including a <1% rate of failure per year, as stated in the product label

          -  Oral Contraceptive, either combined or progestogen alone. Injectable progestogen

          -  Contraceptive vaginal ring

          -  Percutaneous contraceptive patches These allowed methods of contraception are only
             effective when used consistently, correctly and in accordance with the product label.
             The investigator is responsible for ensuring that subjects understand how to properly
             use these methods of contraception.

          -  Capable of giving written informed consent, which includes compliance with the
             requirements and restrictions listed in the consent form.

        Exclusion Criteria:

          -  Alanine aminotransferase (ALT) and bilirubin >1.5 x upper limit of normal (ULN)
             (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
             bilirubin <35%).

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones)

          -  Corrected QT (QTC) > 450 milliseconds (msec)

          -  NOTES: The QTc is the QT interval corrected for heart rate according to Bazett's
             formula (QTcB), Fridericia's formula (QTcF), and/or another method, machineread or
             manually over-read.

          -  The specific formula that will be used to determine eligibility and discontinuation
             for an individual subject should be determined prior to initiation of the study. In
             other words, several different formulae cannot be used to calculate the QTc for an
             individual subject and then the lowest QTc value used to include or discontinue the
             subject from the trial.

          -  For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a
             composite of available values of QTc will be used as specified in the Reporting and
             Analysis Plan (RAP).

          -  No concomitant medications should be taken by the subject while participating in the
             study. Refer to Study Protocol for further detail.

          -  History of regular alcohol consumption within 6 months of the study defined as: An
             average weekly intake of >21 units for males or >14 units for females. One unit is
             equivalent to 8 grams of alcohol: a half-pint (~240 milliliters [mL]) of beer, 1 glass
             (125 mL) of wine or 1 (25 mL) measure of spirits.

          -  Urinary cotinine levels indicative of smoking or history or regular use of tobacco or
             nicotine-containing products within 6 months prior to screening.

          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.

          -  History of sensitivity to any of the study medications, or components thereof or a
             history of drug or other allergy that, in the opinion of the investigator or Medical
             Monitor, contraindicates their participation.

          -  Subjects with phenylketonuria

          -  Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test
             result at screening or within 3 months prior to first dose of study treatment. For
             potent immunosuppressive agents, subjects with presence of hepatitis B core

          -  A positive pre-study drug/alcohol screen.

          -  A positive test for Human Immunodeficiency Virus (HIV) antibody.

          -  Where participation in the study would result in donation of blood or blood products
             in excess of 500 mL within a 90 day period.

          -  The subject has participated in a clinical trial and has received an investigational
             product within the following time period prior to the first dosing day in the current
             study: 90 days, 5 half-lives or twice the duration of the biological effect of the
             investigational product (whichever is longer).

          -  Exposure to more than four new chemical entities within 12 months prior to the first
             dosing day.

          -  Gastrointestinal disease or with gastrointestinal surgical history which can affect
             the absorption of the investigational drug.

          -  Any symptoms with a systolic Blood pressure (BP) <95 millimeters of mercury (mmHg)

          -  Pregnant females as determined by positive serum hCG test at screening or prior to
             dosing

          -  Lactating females
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 65 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Entailment