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famotidine calcium carbonate magnesium hydroxide

Phase 1

Heartburn | Small molecule | Gastrointestinal |Johnson & Johnson|Last Updated: Jun 24, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

famotidine calcium carbonate magnesium hydroxide · 1 trial · 1 indication

Phase 1 1
NCT00944671A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)Heartburn
COMPLETED24 Analytics
PHASE1COMPLETED
A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
Heartburn
NCT0094467124
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Study Endpoints

Primary Endpoints

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

Secondary Endpoints

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATORFamotidine/antacid combination tablet with water
BEXPERIMENTALFamotidine/Antacid EZ Chew tablet without water
CEXPERIMENTALFamotidine/Antacid EZ Chew tablet with water

Interventions

NameTypeDescription
famotidine (+) calcium carbonate (+) magnesium hydroxide tabletDRUGA single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods
Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without waterDRUGA single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods
Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with waterDRUGA single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Female subject is not pregnant or lactating, Females of childbearing potential must use reliable means of contraception during the course of the study * Subject is in good health * Subject is able to abstain from smoking during the 24-hour periods before and during each treatm...

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