Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Famotidine FCT · 1 trial · 1 indication
AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
| Arm | Type | Description |
|---|---|---|
| Sequence 1: FCT with water → CT without water → CT with water | EXPERIMENTAL | Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3). |
| Sequence 2: CT without water → CT with water → FCT with water | EXPERIMENTAL | Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3). |
| Sequence 3: CT with water → FCT with water → CT without water | EXPERIMENTAL | Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3). |
| Sequence 4: FCT with water → CT with water → CT without water | EXPERIMENTAL | Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3). |
| Sequence 5: CT without water → FCT with water → CT with water | EXPERIMENTAL | Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3). |
| Sequence 6: CT with water → CT without water → FCT with water | EXPERIMENTAL | Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3). |
| Name | Type | Description |
|---|---|---|
| Famotidine FCT | DRUG | Famotidine 20 mg oral film-coated tablet taken once daily |
| Famotidine CT | DRUG | Famotidine 20 mg oral chewable tablet taken once daily |
Inclusion Criteria: * Female participant is not pregnant or lactating * Female of childbearing potential must use reliable means of contraception during the course of the study * Is in good health * Is able to abstain from smoking during the 24-hour periods before and during each treatment day Exc...