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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00803790 | A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253) | PHASE1 | COMPLETED | 318 | — | — | May 1, 2006 | Jul 1, 2006 | Feb 3, 2022 | - | — |
Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.
The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
| Arm | Type | Description |
|---|---|---|
| Sequence 1- alendronate+vitamin D combination then alendronate | EXPERIMENTAL | Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period. |
| Sequence 2 alendronate then alendronate+vitamin D combination | EXPERIMENTAL | Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period. |
| Sequence 3 alendronate+vitamin D combination then vitamin D | EXPERIMENTAL | Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period. |
| Sequence 4- vitamin D then alendronate+vitamin D combination | EXPERIMENTAL | Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period. |
| Name | Type | Description |
|---|---|---|
| alendronate sodium+vitamin D combination | DRUG | A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence. |
| Comparator: alendronate | DRUG | A single dose tablet of 70mg alendronate in one treatment period of each sequence. |
| Comparator: Vitamin D | DIETARY_SUPPLEMENT | Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence. |
Inclusion Criteria: * Male or nonpregnant female age 18 to 85 years * female of childbearing potential on appropriate method of contraception and not nursing * Body Mass Index (BMI) less than or equal to 30 kg/m2 * subject is in good health Exclusion Criteria: * mental or legal incapacitation * r...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | NA | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | — | Undisclosed |