Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00925704 | The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers | PHASE1 | COMPLETED | 41 | — | — | Jun 1, 2009 | Jul 31, 2009 | Jun 15, 2021 | 1 | United States |
This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.
| Arm | Type | Description |
|---|---|---|
| Calcitriol | ACTIVE_COMPARATOR | - |
| Lanthanum carbonate + calcitriol | EXPERIMENTAL | - |
| Sevelamer carbonate + calcitriol | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Calcitriol | DRUG | Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. |
| Lanthanum carbonate + Calcitriol | DRUG | Lanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. |
| Sevelamer carbonate + Calcitriol | DRUG | Sevelamer carbonate (2400 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. |
Inclusion criteria * Healthy volunteers age 19-45 years inclusive at the time of consent. * Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, ...