A Phase I, Single-Centre, Double-Blind, Randomized, Placebo-Controlled Clinical Trial To Determine Urinary Xylose Cut-Off Point For The Diagnosis Of Hypolactasia, After A Single Dose Of Gaxilose in Children Between 5 – 11 Years Of Age.

INTERVENTION: Product Name: LacTEST 0,45 g polvo para solución oral.,Product Code: PRD2291455,Pharmaceutical Form: ORAL SOLUTION,Other descriptive name: ,Strength: Gaxilose 0.45g CONDITION: Hypolactasia Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: Main Objective:To establish a urinary cut‐off point of xylose after a single dose of Gaxilose (LacTEST 0,45g) in healthy subjects between 5 ‐ 11 years of age, for the diagnosis of hypolactasia. Primary end point(s):PK analysis for urinary xylose excretion will be based on the following parameters: maximum urinary excretion rate detected at 0‐3, 3‐4 and 4‐5h; its mean time during the corresponding interval (Tmax) and total xylose excreted (Ae0‐5). All urine samples will be analyzed at a laboratory located in Hospital Universitario de Getafe Secondary Objective:To assess the safety and tolerability of a single oral dose of 0.45g of Gaxilose in subjects between 5 ‐ 11 years of age. SECONDARY OUTCOME: Secondary end point(s):The incidence of adverse events (AEs), as well as relevant and abnormal changes from baseline in laboratory test results, and changes to vital signs in the treatment arm compared to the control arm. INCLUSION CRITERIA: Either male of female children between 5 or 11 years of age.,Participant’s parent(s)/legal guardian(s) are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.,Subjects in good health with no baseline gastrointestinal condition.,Participants that regularly consume lactose containing products and have no signs or symptoms that could be associated with intestinal lactase deficiency (Participants will be inquire about this aspect at screening visit).