Pseudoephedrine hydrochloride for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- VO2max > 60ml/min/kg bodymass (men)"}
• {"criterion_text":"- VO2max > 50ml/min/kg bodymass (women)"}
• {"criterion_text":"- Having a mean trainingvolume of more than 10 hours per week of which > 3 hours of cycling training"}
• {"criterion_text":"- Medical approval to compete in competition sport"}
• {"criterion_text":"- Between 18-40 years of age"}
• {"criterion_text":"- Actively using combined (estrogen and progestogen containing) or progestogen-only hormonal birth control according to the guidelines for longer than 1 month (only for women)"}
• {"criterion_text":"- Dutch speaking"}

Exclusion criteria

• {"criterion_text":"- Engaging in competition during the full duration of the study"}
• {"criterion_text":"- Vaccination or blood donation in the last 3 weeks leading up to the study and during the study"}
• {"criterion_text":"- Pregnant women (A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.)"}
• {"criterion_text":"- Breastfeeding women"}
• {"criterion_text":"- Smoking"}
• {"criterion_text":"- History of cardiac arrhythmias, coronary artery disease, cerebrovascular accident (stroke), severe hypertension, hyperthyroidism (overactive thyroid), severe renal insufficiency (impaired kidney function) and glaucoma (increased intraocular pressure)"}
• {"criterion_text":"- Use of antidepressants such as monoamine oxidase (MAO) inhibitors or tricyclic antidepressants that should not be combined with pseudoephedrine Phenelzine (Nardil zine), Moclobemide, Amitriptyline (Redomex), Clomipramine (Anafranil), Dosulepin (Prothiaden), Imipramine (Tofranil), Nortriptyline (Nortrilen))"}
• {"criterion_text":"- Rare hereditary conditions such as galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption"}
• {"criterion_text":"- Use of products containing aluminium hydroxide (Maalox Antacid, Gaviscon)"}
• {"criterion_text":"- Use of other products for nasal decongestion, appetite suppressants, stimulant medications (psychostimulants) of the amphetamine type and medications for diabetes, or high blood pressure."}
• {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients"}
• {"criterion_text":"- Diabetes"}
• {"criterion_text":"- Enlarged prostate or multiple symptoms that could indicate an enlarged prostate"}
• {"criterion_text":"- Unable to give informed consent"}
• {"criterion_text":"- Enrolled in another drug trial"}
• {"criterion_text":"- Injuries sustained within the 3 months prior to the study that resulted in a break from sports participation for 2 weeks or longer"}
• {"criterion_text":"- Ingestion of supplements, medication and/or drugs in the last week leading up to the study and during the study"}

Primary endpoints

• {"endpoint_text":"- Change in time trial duration (and average power output) when the placebo trial (0 mg) is compared to the trial with ingestion of 240 mg Pseudoephedrine","definition_or_measurement_approach":"Change measured as difference in time trial duration and average power output comparing placebo (0 mg) versus 240 mg pseudoephedrine during the cycling time trial (after the exhausting race simulation)."}

Secondary endpoints

• {"endpoint_text":"- Changes in physiological parameters (cardiovascular, oxidative and metabolic) during the 90’ long cycling race simulation when the placebo trial (0 mg) is compared to the trial with ingestion of 120 mg Pseudoephedrine","definition_or_measurement_approach":"Measured changes in cardiovascular, oxidative and metabolic physiological parameters during the 90-minute cycling simulation comparing 0 mg vs 120 mg pseudoephedrine."}
• {"endpoint_text":"- Changes in physiological parameters (cardiovascular, oxidative and metabolic) during the 90’ long cycling race simulation when the placebo trial (0 mg) is compared to the trial with ingestion of 240 mg Pseudoephedrine","definition_or_measurement_approach":"Measured changes in cardiovascular, oxidative and metabolic physiological parameters during the 90-minute cycling simulation comparing 0 mg vs 240 mg pseudoephedrine."}
• {"endpoint_text":"- The upper limit of the 95% CI of the mean maximal measured blood/urine pseudoephedrine concentration after ingestion of 240 mg of pseudoephedrine for each sampling method (TASSO+, VAMS, DBS, Venapuncture and urine collection)","definition_or_measurement_approach":"Determination of the upper limit of the 95% confidence interval of the mean maximal measured pseudoephedrine concentration for each sampling method listed (TASSO+, VAMS, DBS, venapuncture and urine)."}
• {"endpoint_text":"- Change in time trial duration (and average power output) when the half-dose trial (120 mg) is compared to the trial with ingestion of 0 mg Pseudoephedrine.","definition_or_measurement_approach":"Change measured as difference in time trial duration and average power output comparing 120 mg vs 0 mg pseudoephedrine."}
• {"endpoint_text":"- Change in time trial duration (and average power output) when the half-dose trial (120 mg) is compared to the trial with ingestion of 240 mg Pseudoephedrine.","definition_or_measurement_approach":"Change measured as difference in time trial duration and average power output comparing 120 mg vs 240 mg pseudoephedrine."}

Belgium

Earliest CTIS Part Ii Submission Date

18-04-2025

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

361

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Universiteit Gent

Organisation Type

Educational Institution

Country Of Registered Address

Belgium