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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00880750 | Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults | PHASE1 | COMPLETED | 72 | — | — | Jan 28, 2009 | Jun 22, 2009 | Jun 11, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Lanthanum carbonate granules | EXPERIMENTAL | Lanthanum carbonate granulated formulation crossover to chewable tablet formulation |
| Lanthanum carbonate chewable tablets (Fosrenol) | EXPERIMENTAL | Lanthanum carbonate chewable table formulation crossover to granulated formulation |
| Name | Type | Description |
|---|---|---|
| Lanthanum carbonate Granule Formulation | DRUG | 3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.) |
| Lanthanum carbonate Chewable Tablets (Fosrenol) | DRUG | 3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.) |
Inclusion Criteria * Ability to provide informed consent to participate in the study. * Healthy volunteers, age 18-55 inclusive. * Subject must be willing to comply with applicable contraceptive requirements of the protocol * Female subjects must have a negative pregnancy test * Ability to chew and...