Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dexlansoprazole Orally Disintegrating · 1 trial · 1 indication
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.
AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.
AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours).
| Arm | Type | Description |
|---|---|---|
| Dexlansoprazole OD Tablets + Dexlansoprazole Capsules | EXPERIMENTAL | Two Dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2. |
| Dexlansoprazole Capsules + Dexlansoprazole OD | EXPERIMENTAL | Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2. |
| Name | Type | Description |
|---|---|---|
| Dexlansoprazole Delayed Release Orally Disintegrating Tablets | DRUG | Dexlansoprazole delayed-release, orally disintegrating (OD) tablets |
| Dexlansoprazole Delayed Release Capsules | DRUG | Dexlansoprazole delayed-release capsules |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...
Dexlansoprazole Orally Disintegrating is a small molecule drug developed by Takeda Pharmaceutical Company Limited. It is also known as Dexlansoprazole Delayed Release Orally Disintegrating Tablets. The drug is designed to be taken orally and disintegrates in the mouth. It is currently in Phase 1 clinical development.
Dexlansoprazole Orally Disintegrating targets ATP4A and ATP4B. These are subunits of the gastric proton pump, and the drug acts as an inhibitor. By inhibiting this target, it reduces gastric acid secretion. This mechanism is relevant for conditions where acid suppression is beneficial.
Dexlansoprazole Orally Disintegrating is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is a global pharmaceutical company. The drug is part of their pipeline for acid-related disorders.
Dexlansoprazole Orally Disintegrating is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed, and further development may be ongoing.
Dexlansoprazole Orally Disintegrating has been studied in one completed Phase 1 clinical trial, NCT02064907. This trial evaluated bioavailability, safety, and pharmacodynamics in healthy participants. It enrolled 52 participants and was conducted in the United States.