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...