To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers
Condition: Common Cold
MeSH terms: Common Cold
Intervention: Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg; Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg
Intervention description: Contents of the sachet will be emptied into a glass bottle and 225 mL of hot, but not boiling water (approximately 90-95°C), will be added to the container and mixed to dissolve the contents of the sachet. The dissolved solution will be allowed to cool to approximately 40 - 50 degree Celsius (°C). After cooling, a small volume (1 to 10 microliters [mcL]) of 99mTc-DTPA (Technetium-99m-diethylene-triamine-pentaacetate will be added to the drug solution in to achieve a maximum of 108 curie(mcCi) i.e.4 megabecquerel [MBq] per individual dose at the time of dosing. The container will be capped and maintained at a temperature between 35-45°C at time of dosing and then participants will be instructed to consume the hot drink entirely within 30 seconds.; Caplet doses will be prepared by drilling hole of approximately(app.)1millimetre(mm)diameter and app.2-2.5mm deep into individual caplets.99mTc-DTPA(dissolved in normal saline)will be added into hole of each caplet as low volume liquid(0.5-2.0mcL)to achieve maximum of 54 mcCi(2MBq)per caplet at time of dosing(2caplets=108 mcCi[4MBq]dose per assessment visit).Applied liquid will be allowed to air dry,hole to be filled with equivalent powder blend from crushed caplet so drug content will remain constant for all caplets.Caplet will be sealed with appropriate material.Radiolabeled caplets will be packaged as unit doses(2 caplets per container)and maintained at room temperature until administration.Caplets will be swallowed with 225mL of noncarbonated room temperature water within 30 seconds.
Intervention MeSH terms: Acetaminophen; Phenylephrine; Oxymetazoline; Dextromethorphan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This clinical study will be conducted to characterize the gastrointestinal transit of two
      multi-symptoms formulations by inclusion of a radiolabel marker.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject has been informed of all pertinent aspects of the study before any
             assessment is performed.

          -  Healthy male participants who, at the time of screening, are between the ages of 21
             and 45 years, inclusive.

          -  Participants who are willing and able to comply with scheduled visits, treatment plan,
             bio-imaging procedure, laboratory tests and other study procedures.

          -  Healthy participant which is defined as in general good physical health, as judged by
             the investigator and no clinically relevant abnormalities identified by a detailed
             medical history, full physical examination, including blood pressure and pulse rate
             measurement, 12-lead Electrocardiogram (ECG) or clinical laboratory tests.

          -  Body Mass Index (BMI) of 17.5 to 30.5 kilogram per meter square (kg/m2); and a total
             body weight >50 kg (110 lbs)

        Exclusion Criteria:

          -  Participants who are investigational site staff members directly involved in the
             conduct of the study and their family members, site staff members otherwise supervised
             by the investigator, or participants who are GSK employees directly involved in the
             conduct of the study.

          -  Participation in other studies involving investigational drug(s) within 30 days prior
             to study entry and/or during study participation.

          -  Acute or chronic medical or psychiatric condition or laboratory abnormality that may
             increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  Known or suspected intolerance or hypersensitivity or contraindication to the study
             materials (or closely related compounds) or any of their stated ingredients.

          -  Participant with known allergy or intolerance to any of the contents of the standard
             meals.

          -  Participant is vegetarian.

          -  Unwilling or unable to comply with the Lifestyle guidelines described in this
             protocol.

          -  Use of prescription or non-prescription drugs and dietary supplements within 14 days
             or 5 half-lives, whichever is longer, prior to the first dose of investigational
             product that are deemed by the investigator to have a potential impact on the study
             objectives results.

          -  Evidence or history of clinically significant laboratory abnormality, hematological,
             renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease within the last 5 years that may increase the risk associated with
             study participation.

          -  A positive urine drug screen, breath alcohol test or urine cotinine test during
             Screening or on Day -1 of the study.

          -  Any condition possibly affecting drug absorption (e.g., gastrectomy)

          -  A history of current or relevant previous non-self-limiting gastrointestinal disorders
             peptic ulcer disease and/or gastrointestinal bleeding.

          -  Currently suffering from disease known to impact gastric emptying, e.g. migraine,
             insulin-dependent diabetes mellitus.

          -  The participant has had radiation exposure from clinical trials, including from the
             present study, and from therapeutic or diagnostic exposure, but excluding background
             radiation, exceeding a target organ (colon) dose of 50 mSv (5 rems) from a single dose
             within the last 30 days or a cumulative dose of 150 mSv (15 rems) in the last 12
             months. No participant whose occupation requires monitoring for radiation exposure
             will be enrolled in the study.

          -  Participants who have been exposed to ionising radiation in excess of 10 mSv (whole
             body effective dose) above background over the previous 3 years period as a result of
             occupational exposure or previous participation in research studies. Clinically
             justified (therapeutic or diagnostic) exposures are not included in this calculation.

          -  Renal disease or impaired renal function at screening as indicated by abnormal levels
             of serum creatinine or urea or the presence of clinically significant abnormal urinary
             constituents (e.g. albuminuria). Minor deviations of laboratory values from the normal
             range are permitted, if judged by the investigator to have no clinical relevance.

          -  History or current evidence of ongoing hepatic disease or impaired hepatic function at
             screening. A candidate will be excluded if more than one of the following lab value
             deviations are found: 1) AST/SGOT (≥ 1.2 ULN), ALT/SGPT (≥ 1.2 ULN), 2) GGT (≥ 1.2
             ULN), ALP (≥ 1.2 ULN), 3) total bilirubin (≥ 1.2 mg/dL) Minor deviations of laboratory
             values from the normal range are permitted, if judged by the investigator to have no
             clinical relevance. Positive results in any of the virology tests for HIV-Ab, HCV-Ab,
             HBsAg and HBc-Ab (Total).

          -  Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.

          -  Participants who were intending to father a child in the 3 months following the study.

          -  Participants who were unwilling to follow contraception requirements

          -  Participant had any non-removable metal objects such as metal plates, screws etc. in
             their chest or abdominal area.

          -  History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces
             (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor)
             within 6 months of Screening.

          -  Smokers defined as the use of tobacco products (including but not limited to:
             electronic-cigarettes, nicotine gums, nicotine lozenges, etc) during the 6 months
             prior to screening or a positive urine cotinine test at screening.

          -  Participant has consumed (eat or drink) grapefruit or grapefruit-related citrus fruits
             (e.g., Seville oranges, pomelos, pawpaw, dragon fruit, kiwi fruit, mango, passion
             fruit, pomegranate, rambutan, star fruit or products that contain these fruits) 14
             days prior to the first dose of investigational product.

          -  Participants who have previously been enrolled in this study.