To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 1

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

Detailed description: 
      This study will be an open label, randomized, single dose, parallel groups gamma
      scintigraphic study. A total of 28 healthy male participants will be randomized (14
      participantper treatment arm) in order to have 24 evaluable participants (12 participants per
      treatment arm). Participants will be randomized to receive either a single dose Treatment A
      (Theraflu daytime Severe Cold & Cough powder) or single dose of Treatment B (Theraflu
      ExpressMax Daytime Severe Cold and Cough caplets). This study will consist of screening visit
      (Visit 1), followed by a treatment visit (Visit 2). Visit 2 includes two days: Day -1 and Day
      1. On visit 2 (day -1) of the study, the study participants will be admitted to the unit at
      approximately 7 pm on the evening before study drug administration and will receive a
      standardized meal. Participants will be required to fast (nothing to eat or drink except
      non-carbonated water) from 10 hours prior until 4 hours after study drug administration.
      Water will be permitted until 1 hour prior to investigational product administration, and no
      additional fluids until the lunch meal will be served at approximately 4 hours post dose.
      Participants will then be given a standard lunch at 4 hours post-dose, a standard dinner at
      10 hours post-dose on Day 1. Participants will be discharged from the unit after the last
      scintigraphic imaging is performed, blood sample for laboratory test will be taken as well as
      a brief physical examination. Scintigraphic acquisitions will be taken beginning after dose
      administration until 10 hours post-dose.
    

Intervention name(s): Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg; Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Theraflu daytime severe cold and cough powder; Theraflu expressmax daytime severe cold and cough caplets
Intervention MeSH terms: Acetaminophen; Phenylephrine; Oxymetazoline; Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment