Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Decitabine-THU · 1 trial · 1 indication
Measured in hours\*nanogram per milliliter (h\*ng/mL).
| Arm | Type | Description |
|---|---|---|
| Formulation A followed by Formulation B | EXPERIMENTAL | Participants will receive a single oral dose of decitabine and tetrahydrouridine (THU) immediate release tablets (Formulation A) on Day 1 of treatment period 1 followed by a single oral dose of decitabine and THU delayed release capsules (Formulation B) on Day 1 of treatment period 2. A washout period of 7- 21 days will be maintained between the two treatment periods. |
| Formulation B followed by Formulation A | EXPERIMENTAL | Participants will receive a single oral dose of decitabine and THU delayed release capsules (Formulation B) on Day 1 of treatment period 1 followed by a single oral dose of decitabine and THU immediate release tablets (Formulation A) on Day 1 of treatment period 2. A washout period of 7- 21 days will be maintained between the two treatment periods. |
| Name | Type | Description |
|---|---|---|
| Decitabine-THU | DRUG | Orally administered immediate release tablets. |
Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female. * Age 18 64 years (both inclusive) at the time o...