P2-study
Completed
- Conditions
- one: healthy volunteers
- Registration Number
- NL-OMON25128
- Lead Sponsor
- utricia Research
- Brief Summary
https://www.sciencedirect.com/science/article/pii/S0271531720305698
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Age ≥ 18 and ≤ 40 years
- Body Mass Index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2
Exclusion Criteria
- Any medical condition that interferes significantly with digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphraghma hernia or diaphraghma surgery, gastric ulcer, gastritis, (gastro)enteritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator
- Known renal or hepatic failure or known thyroid dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome parameter in this study is serum P AUC0-360 [mmol/L*min] (product A compared to product B).
- Secondary Outcome Measures
Name Time Method The secondary outcome parameters in this study are comparisons of product A and B on:<br /><br>-Serum P [mmol/L] Cmin [mmol/L] and Tmin [min]<br /><br>-Urinary P [mmol/L] Cmax [mmol/L], AUC70-370 [mmol/L*min] and Tmax [min]<br /><br>-Serum Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC0-360 [mmol/L*min], iAUC0-360 [mmol/L*min] and Tmax [min]<br /><br>-Urinary Ca [mmol/L], Cmax [mmol/L], iCmax [mmol/L], AUC70-370 [mmol/L*min], iAUC70-370 [mmol/L*min] and Tmax [min]<br>