Trial Outcomes & Findings for A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144) (NCT NCT00945750)
NCT ID: NCT00945750
Last Updated: 2017-03-10
Results Overview
AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Results posted on
2017-03-10
Participant Flow
Participants were randomized to 1 of 6 treatment sequences of 1 of 3 treatments: (1) famotidine as a film-coated tablet (FCT) taken with water, (2) famotidine as a chewable tablet (CTw) taken with water, and (3) famotidine as a chewable tablet taken without water, over 3 study periods in a crossover design.
Participant milestones
| Measure |
FCT With Water / CT Without Water / CT With Water
Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
|
CT Without Water / CT With Water / FCT With Water
Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
|
CT With Water / FCT With Water / CT Without Water
Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
|
FCT With Water / CT With Water / CT Without Water
Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
|
CT Without Water / FCT With Water / CT With Water
Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
|
CT With Water / CT Without Water / FCT With Water
Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
|
|---|---|---|---|---|---|---|
|
Period I
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period I
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period II
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period II
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period III
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Period III
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
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 Chewable Tablets and Film-Coated Tablets (0208-144)
Baseline characteristics by cohort
| Measure |
FCT With Water / CT Without Water / CT With Water
n=5 Participants
Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
|
CT Without Water / CT With Water / FCT With Water
n=5 Participants
Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
|
CT With Water / FCT With Water / CT Without Water
n=5 Participants
Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
|
FCT With Water / CT With Water / CT Without Water
n=5 Participants
Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
|
CT Without Water / FCT With Water / CT With Water
n=5 Participants
Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
|
CT With Water / CT Without Water / FCT With Water
n=5 Participants
Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 5.32 • n=93 Participants
|
24.0 years
STANDARD_DEVIATION 7.38 • n=4 Participants
|
24.2 years
STANDARD_DEVIATION 4.38 • n=27 Participants
|
22.6 years
STANDARD_DEVIATION 3.51 • n=483 Participants
|
26.4 years
STANDARD_DEVIATION 6.11 • n=36 Participants
|
25.6 years
STANDARD_DEVIATION 6.50 • n=10 Participants
|
25.9 years
STANDARD_DEVIATION 6.09 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Weight
|
137.6 Pounds
n=93 Participants
|
163.0 Pounds
n=4 Participants
|
175.4 Pounds
n=27 Participants
|
147.9 Pounds
n=483 Participants
|
142.6 Pounds
n=36 Participants
|
180.4 Pounds
n=10 Participants
|
157.4 Pounds
n=115 Participants
|
PRIMARY outcome
Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dosePopulation: Participants who completed the study
AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Outcome measures
| Measure |
Famotidine 20 mg CT Without Water
n=30 Participants
Famotidine 20 mg CT without water
|
Famotidine 20 mg FCT With Water
n=30 Participants
Famotidine 20 mg FCT with 120 mL of water
|
|---|---|---|
|
Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
|
398.5 ng/mL hr
Interval 350.9 to 452.6
|
394.8 ng/mL hr
Interval 347.6 to 448.4
|
PRIMARY outcome
Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dosePopulation: Participants who completed the study
Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Outcome measures
| Measure |
Famotidine 20 mg CT Without Water
n=30 Participants
Famotidine 20 mg CT without water
|
Famotidine 20 mg FCT With Water
n=30 Participants
Famotidine 20 mg FCT with 120 mL of water
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
|
67.2 ng/mL
Interval 58.7 to 76.9
|
65.1 ng/mL
Interval 56.9 to 74.5
|
SECONDARY outcome
Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dosePopulation: Participants who completed the study
AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Outcome measures
| Measure |
Famotidine 20 mg CT Without Water
n=30 Participants
Famotidine 20 mg CT without water
|
Famotidine 20 mg FCT With Water
n=30 Participants
Famotidine 20 mg FCT with 120 mL of water
|
|---|---|---|
|
AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
|
440.1 ng/mL hr
Interval 387.5 to 499.8
|
394.8 ng/mL hr
Interval 347.6 to 448.4
|
SECONDARY outcome
Timeframe: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dosePopulation: Participants who completed the study
Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Outcome measures
| Measure |
Famotidine 20 mg CT Without Water
n=30 Participants
Famotidine 20 mg CT without water
|
Famotidine 20 mg FCT With Water
n=30 Participants
Famotidine 20 mg FCT with 120 mL of water
|
|---|---|---|
|
Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
|
73.0 ng/mL
Interval 63.8 to 83.6
|
65.1 ng/mL
Interval 56.9 to 74.5
|
Adverse Events
Famotidine 20 mg FCT With Water
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Famotidine 20 mg CT Without Water
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Famotidine 20 mg CT With Water
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Famotidine 20 mg FCT With Water
n=30 participants at risk
Famotidine 20 mg FCT (film-coated tablet) with 120 mL of water
|
Famotidine 20 mg CT Without Water
n=30 participants at risk
Famotidine 20 mg Chewable Tablet without water
|
Famotidine 20 mg CT With Water
n=30 participants at risk
Famotidine 20 mg chewable tablet with 120 mL of water
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • Up to 31 days (including 14 day follow-up)
|
3.3%
1/30 • Number of events 1 • Up to 31 days (including 14 day follow-up)
|
0.00%
0/30 • Up to 31 days (including 14 day follow-up)
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Number of events 4 • Up to 31 days (including 14 day follow-up)
|
10.0%
3/30 • Number of events 3 • Up to 31 days (including 14 day follow-up)
|
10.0%
3/30 • Number of events 4 • Up to 31 days (including 14 day follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/30 • Up to 31 days (including 14 day follow-up)
|
0.00%
0/30 • Up to 31 days (including 14 day follow-up)
|
3.3%
1/30 • Number of events 1 • Up to 31 days (including 14 day follow-up)
|
|
Vascular disorders
Syncope vasovagal
|
3.3%
1/30 • Number of events 1 • Up to 31 days (including 14 day follow-up)
|
0.00%
0/30 • Up to 31 days (including 14 day follow-up)
|
0.00%
0/30 • Up to 31 days (including 14 day follow-up)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by Merck as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER