P-study
Completed
- Conditions
- healthy volunteers
- Registration Number
- NL-OMON25579
- Lead Sponsor
- utricia Research
- Brief Summary
o
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Age ≥ 18 and ≤ 40 years
- Non-Asian race*
Exclusion Criteria
- Any medical condition that interferes significantly with digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, diaphraghma hernia or diaphraghma surgery, gastric ulcer, gastritis, (gastro)enteritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery)
- 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 the serum P AUC(0-360) [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] (product A - B), Cmax, iCmax [mmol/L], Tmax [min]<br /><br>- Serum Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC(0-360) [mmol/L*min], iAUC(0-360) [mmol/L*min], Tmax [min]<br /><br>- Serum creatinine [µmol/L] (product A - B), Cmax, AUC0-360 [µmol/L*min], Tmax [min]<br /><br>- Serum iPTH [pmol/L] (product A - B), Cmax, AUC0-360 [pmol/L*min], Tmax [min]<br /><br>- Serum AP [U/L] (product A - B), Cmax, AUC0-360 [U/L*min], Tmax [min] <br /><br><br /><br>- Urinary P [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC(0-370) [mmol/L*min], iAUC0-370 [mmol/L*min] and Tmax [min]<br /><br>- Urinary Ca [mmol/L] (product A - B), Cmax, iCmax [mmol/L], AUC(0-370) [mmol/L*min], iAUC0-370 [mmol/L*min] and Tmax [min]<br /><br>- Urinary creatinine [mmol/L] (product A - B), Cmax, AUC(0-370) [mmol/L*min] and Tmax [min]<br>