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| Name | Class |
|---|---|
| Second Hospital of Shanxi Medical University | OTHER |
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Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomalidomide 4 MG Oral Capsule | Experimental | per os,capsule,4mg,1 capsule per period |
|
| Pomalidomide 4 MG Oral Capsule-Pomalyst | Experimental | per os,capsule,4mg,1 capsule per period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide 4 MG Oral Capsule | Drug | per os,capsule,4mg,1 capsule per period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 90% CI of T/R within 80-125% | Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. |
| Area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC0-t) | 90% CI of T/R within 80-125% | Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. |
| Area under the plasma concentration versus time curve from 0 to infinity (AUC0-inf) | 90% CI of T/R within 80-125% | Day 1, Day 2, Day 3 of cycle 1, Day 8, Day 9, Day 10 of cycle 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruigang Hou, Bachelor | Second Hospital of Shanxi Medical University | Principal Investigator |
| Linhua Linhua, PhD | Second Hospital of Shanxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second hospital of shanxi medical university | Taiyuan | Shanxi | 030001 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
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two-way crossover
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| Pomalidomide 4 MG Oral Capsule-Pomalyst | Drug | per os,capsule,4mg,1 capsule per period |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |