Trial Outcomes & Findings for A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED) (NCT NCT00944671)
NCT ID: NCT00944671
Last Updated: 2015-06-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Results posted on
2015-06-24
Participant Flow
The study was conducted at a single clinical research center in the US. Subjects were recruited via print advertisements and existing patient research files.
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.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|---|
|
Period I
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period I
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period II
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period II
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period III
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period III
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Period III
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Famotidine With Water/EZ Chew Without Water/EZ Chew With Water
n=4 Participants
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
|
EZ Chew Without Water/EZ Chew With Water/Famotidine With Water
n=4 Participants
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
|
EZ Chew With Water/Famotidine With Water/EZ Chew Without Water
n=4 Participants
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
|
Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water
n=4 Participants
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
|
EZ Chew Without Water/Famotidine With Water/EZ Chew With Water
n=4 Participants
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
|
EZ Chew With Water/EZ Chew Without Water/Famotidine With Water
n=4 Participants
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
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.8 years
n=5 Participants
|
30.0 years
n=7 Participants
|
29.8 years
n=5 Participants
|
26.3 years
n=4 Participants
|
30.8 years
n=21 Participants
|
25.0 years
n=8 Participants
|
28.6 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
9 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
14 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Weight
|
164.1 Pounds
n=5 Participants
|
152.2 Pounds
n=7 Participants
|
160.4 Pounds
n=5 Participants
|
164.8 Pounds
n=4 Participants
|
168.8 Pounds
n=21 Participants
|
165.3 Pounds
n=8 Participants
|
162.6 Pounds
n=8 Participants
|
PRIMARY outcome
Timeframe: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)Outcome measures
| Measure |
Famotidine/Antacid Combination EZ Chew Tablet Without Water
n=24 Participants
|
Famotidine/Antacid Combination Tablet With Water
n=24 Participants
|
|---|---|---|
|
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
Interval 227.9 to 299.3
|
248.0 ng*hr/mL
Interval 216.4 to 284.2
|
PRIMARY outcome
Timeframe: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)Outcome measures
| Measure |
Famotidine/Antacid Combination EZ Chew Tablet Without Water
n=24 Participants
|
Famotidine/Antacid Combination Tablet With Water
n=24 Participants
|
|---|---|---|
|
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
Interval 39.1 to 52.9
|
44.4 ng/mL
Interval 38.1 to 51.7
|
SECONDARY outcome
Timeframe: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)Outcome measures
| Measure |
Famotidine/Antacid Combination EZ Chew Tablet Without Water
n=24 Participants
|
Famotidine/Antacid Combination Tablet With Water
n=24 Participants
|
|---|---|---|
|
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
Interval 227.0 to 298.0
|
248.0 ng*h/mL
Interval 216.4 to 284.2
|
SECONDARY outcome
Timeframe: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)Outcome measures
| Measure |
Famotidine/Antacid Combination EZ Chew Tablet Without Water
n=24 Participants
|
Famotidine/Antacid Combination Tablet With Water
n=24 Participants
|
|---|---|---|
|
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
Interval 39.4 to 53.4
|
44.4 ng/mL
Interval 38.1 to 51.7
|
Adverse Events
Famotidine/Antacid Combination Tablet With Water
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Famotidine/Antacid Combination EZ Chew Tablet Without Water
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Famotidine/Antacid Combination EZ Chew Tablet With Water
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Famotidine/Antacid Combination Tablet With Water
n=24 participants at risk
Famotidine/antacid combination tablet with 120 mL of water
|
Famotidine/Antacid Combination EZ Chew Tablet Without Water
n=24 participants at risk
Famotidine/antacid combination EZ Chew tablet without water
|
Famotidine/Antacid Combination EZ Chew Tablet With Water
n=24 participants at risk
Famotidine/antacid combination EZ Chew tablet with 120 mL of water
|
|---|---|---|---|
|
Reproductive system and breast disorders
Dysmenorrhea
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
16.7%
4/24 • Number of events 4
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
|
Vascular disorders
Syncope vasovagal
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
Additional Information
Executive Vice President, Clinical and Quantitative Sciences
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER