Table 1 Study schedule
Study day | Action |
|---|---|
+30 | Body weight and blood collection for serum phosphate |
Ranking and allocation to groups | |
Start of acclimatization to housing and diets | |
Start of daily general health observations | |
+20 | Body weight |
Clinical examination | |
−16 to −12, −9 to −6 and −1 | Acceptability test |
−14 | Blood collection for chemistry and haematology |
72 hour urine collection (baseline) (−14 to −12) | |
72 hour faeces collection (baseline) (−14 to −12) | |
−1 | Clinical examination |
0 | Start daily administration of Lenziaren® to groups A-D (day 0 to +29) |
Specific health observations (including hourly for 4 hours post administration of test item) | |
0 to +2, +5 to +8, +12 to +14 | Acceptability test |
+6 | 72 hour urine collection (+6 to +9) |
72 hour faeces collection (+6 to +9) | |
+7 | Clinical examination |
Body weight | |
Blood specimen collection | |
+13 | Clinical examination |
72 hour urine collection (+13 to +16) | |
72 hour faeces collection (+13 to +16) | |
+14 | Body weight |
Blood specimen collection | |
+20 | Clinical examination |
72 hour urine collection (+20 to +23) | |
72 hour faeces collection (+20 to +23) | |
+21 | Body weight |
Blood specimen collection | |
+27 | Clinical examination |
72 hour urine collection (+27 to +30) | |
72 hour faeces collection (+27 to +30) | |
+28 | Body weight |
Blood specimen collection | |
+29 | Final administration of Lenziaren® |
+30 | End of biological phase of study |