Conditions: Heartburn
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief summary:
This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.

Detailed description:

Arms:
arm 1: 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). arm 2: 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). arm 3: 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). arm 4: 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). arm 5: 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). arm 6: 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).

Interventions: intervention 1: Famotidine FCT intervention 2: Famotidine CT
Intervention descriptions: intervention 1: Famotidine 20 mg oral film-coated tablet taken once daily intervention 2: Famotidine 20 mg oral chewable tablet taken once daily

Protocol document: