Heartburn
Conditions
Brief summary
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.
Interventions
DRUGfamotidine (+) calcium carbonate (+) magnesium hydroxide tablet
A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods
DRUGComparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water
A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods
DRUGComparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 treatment day
Exclusion criteria
* Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery * Subject has a history of asthma or severe allergies to drugs or foods * Subject currently uses prescribed or nonprescribed drugs on a regular basis * Subject has a recent history of drug/alcohol abuse * Subject consumes more than 6 cups of coffee per day * Subject has unconventional or extreme dietary habits * Subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days * Subject has a history of allergy or intolerance to antacids * Female subject is known to be pregnant or is not using reliable means of contraception
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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 | Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose) |
Participant flow
Recruitment details
The study was conducted at a single clinical research center in the US. Subjects were recruited via print advertisements and existing patient research files.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 4 |
| 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 | 4 |
| 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 | 4 |
| 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 | 4 |
| 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 | 4 |
| Total | 24 |
Baseline characteristics
| Characteristic | Famotidine With Water/EZ Chew Without Water/EZ Chew With Water | EZ Chew Without Water/EZ Chew With Water/Famotidine With Water | EZ Chew With Water/Famotidine With Water/EZ Chew Without Water | Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water | EZ Chew Without Water/Famotidine With Water/EZ Chew With Water | EZ Chew With Water/EZ Chew Without Water/Famotidine With Water | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 29.8 years | 30.0 years | 29.8 years | 26.3 years | 30.8 years | 25.0 years | 28.6 years |
| Race/Ethnicity, Customized Black | 1 participants | 1 participants | 2 participants | 1 participants | 2 participants | 2 participants | 9 participants |
| Race/Ethnicity, Customized Caucasian | 3 participants | 3 participants | 2 participants | 2 participants | 2 participants | 2 participants | 14 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 12 Participants |
| Weight | 164.1 Pounds | 152.2 Pounds | 160.4 Pounds | 164.8 Pounds | 168.8 Pounds | 165.3 Pounds | 162.6 Pounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 24 | 4 / 24 | 5 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
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
Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Famotidine/Antacid Combination EZ Chew Tablet Without Water | 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 | 261.2 ng*hr/mL |
| Famotidine/Antacid Combination Tablet With Water | 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 | 248.0 ng*hr/mL |
90% CI: [0.98, 1.13]
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
Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Famotidine/Antacid Combination EZ Chew Tablet Without Water | Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water | 45.5 ng/mL |
| Famotidine/Antacid Combination Tablet With Water | Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water | 44.4 ng/mL |
90% CI: [0.93, 1.13]
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
Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Famotidine/Antacid Combination EZ Chew Tablet Without Water | 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 | 260.1 ng*h/mL |
| Famotidine/Antacid Combination Tablet With Water | 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 | 248.0 ng*h/mL |
90% CI: [0.98, 1.13]
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
Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Famotidine/Antacid Combination EZ Chew Tablet Without Water | Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water | 45.9 ng/mL |
| Famotidine/Antacid Combination Tablet With Water | Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water | 44.4 ng/mL |
90% CI: [0.93, 1.14]