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...
Famotidine FCT is a chewable tablet formulation of famotidine, a small molecule drug developed by Merck & Company, Inc. (MRK) for heartburn. It is an investigational formulation that has been studied in a Phase 1 clinical trial. Famotidine FCT is not approved by the FDA.
Famotidine FCT is used for the treatment of heartburn. It is being developed by Merck & Company, Inc. (MRK) as a chewable tablet formulation. The drug is in Phase 1 clinical development and has been studied in a bioequivalence trial in healthy volunteers.
Famotidine FCT targets the histamine H2 receptor, also known as HRH2. It acts as an antagonist at this receptor, which reduces gastric acid secretion. This mechanism is consistent with its use for heartburn.
Famotidine FCT is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is responsible for the clinical development of this chewable tablet formulation of famotidine.
Famotidine FCT is in Phase 1 clinical development. It has completed one Phase 1 trial. The drug is investigational and has not been approved by the FDA for any indication.
Famotidine FCT has been studied in one completed Phase 1 clinical trial, NCT00945750, titled "A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)." The trial enrolled 30 healthy adult volunteers and was a randomized, controlled study.