Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009_622 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Famotidine/antacid combination tablet with water |
|
| B | Experimental | Famotidine/Antacid EZ Chew tablet without water |
|
| C | Experimental | Famotidine/Antacid EZ Chew tablet with water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| famotidine (+) calcium carbonate (+) magnesium hydroxide tablet | Drug | A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Prior to the first treatment period, Health Insurance Portability and Accountability Act (HIPAA) and informed consent were signed. For each subject a medical history was taken, physical examination and laboratory safety tests were conducted. No enrolled subjects were excluded from the trial before randomization.
The study was conducted at a single clinical research center in the US. Subjects were recruited via print advertisements and existing patient research files.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Famotidine With Water/EZ Chew Without Water/EZ Chew With Water | Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water |
| FG001 | EZ Chew Without Water/EZ Chew With Water/Famotidine With Water |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period I |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water | Drug | A 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 water | Drug | A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods |
|
| Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) |
Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water |
| FG002 | EZ Chew With Water/Famotidine With Water/EZ Chew Without Water | Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water |
| FG003 | Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water | Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water |
| FG004 | EZ Chew Without Water/Famotidine With Water/EZ Chew With Water | Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water |
| FG005 | EZ Chew With Water/EZ Chew Without Water/Famotidine With Water | Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water |
| COMPLETED |
|
| NOT COMPLETED |
|
| Period II |
|
| Period III |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Famotidine With Water/EZ Chew Without Water/EZ Chew With Water | Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water |
| BG001 | EZ Chew Without Water/EZ Chew With Water/Famotidine With Water | Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water |
| BG002 | EZ Chew With Water/Famotidine With Water/EZ Chew Without Water | Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water |
| BG003 | Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water | Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water |
| BG004 | EZ Chew Without Water/Famotidine With Water/EZ Chew With Water | Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water |
| BG005 | EZ Chew With Water/EZ Chew Without Water/Famotidine With Water | Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Weight | Mean | Full Range | Pounds |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Geometric Mean | 95% Confidence Interval | ng*hr/mL | Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Geometric Mean | 95% Confidence Interval | ng*h/mL | Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Famotidine/Antacid Combination Tablet With Water | Famotidine/antacid combination tablet with 120 mL of water | 0 | 24 | 3 | 24 | ||
| EG001 | Famotidine/Antacid Combination EZ Chew Tablet Without Water | Famotidine/antacid combination EZ Chew tablet without water | 0 | 24 | 4 | 24 | ||
| EG002 | Famotidine/Antacid Combination EZ Chew Tablet With Water | Famotidine/antacid combination EZ Chew tablet with 120 mL of water | 0 | 24 | 5 | 24 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope vasovagal | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015738 | Famotidine |
| D002119 | Calcium Carbonate |
| D008276 | Magnesium Hydroxide |
| D014867 | Water |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D017616 | Magnesium Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
Not provided
Not provided
| Male |
|
| Caucasian |
|
| Native American |
|
|
|
|
|
|
|