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CompletedNCT00945750Updated Mar 10, 2017Results posted

A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)

A Phase 1 interventional study of Famotidine FCT and Famotidine CT in Heartburn, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.

02

Conditions studied

  • Heartburn

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03

In context

Heartburn

154 studies on the registry are indexed under Heartburn; 12 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 127 interventional studies indexed under Heartburn.

Browse Heartburn studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.

Of its 502 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female participant is not pregnant or lactating
  • Female of must use reliable means of during the course of the study
  • Is in good health
  • Is able to abstain from smoking during the 24-hour periods before and during each treatment day

Exclusion criteria

Exclusion Criteria:

  • Has any major systemic disorders
  • Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery
  • Has or has a history of any illness or condition that might interfere with optimal participation in the study
  • Has a history of asthma or severe allergies to drugs or foods
  • Currently uses prescribed or non-prescribed drugs on a regular basis
  • Has a recent history of drug/alcohol abuse
  • Consumes more than 6 cups of coffee per day
  • Has unconventional or extreme dietary habits
  • Has donated blood or has been in a clinical trial in which they received an drug during the past 30 days
  • Has a history of allergy or intolerance to antacids
  • Is known to be pregnant or is not using reliable means of
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Sequence 1: FCT with water → CT without water → CT with water

    Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).

    Drug: Famotidine FCT · Drug: Famotidine CT

  • Experimental
    Sequence 2: CT without water → CT with water → FCT with water

    Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).

    Drug: Famotidine FCT · Drug: Famotidine CT

  • Experimental
    Sequence 3: CT with water → FCT with water → CT without water

    Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).

    Drug: Famotidine FCT · Drug: Famotidine CT

  • Experimental
    Sequence 4: FCT with water → CT with water → CT without water

    Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).

    Drug: Famotidine FCT · Drug: Famotidine CT

  • Experimental
    Sequence 5: CT without water → FCT with water → CT with water

    Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).

    Drug: Famotidine FCT · Drug: Famotidine CT

  • Experimental
    Sequence 6: CT with water → CT without water → FCT with water

    Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).

    Drug: Famotidine FCT · Drug: Famotidine CT

Interventions

  • DrugFamotidine FCT

    Famotidine 20 mg oral film-coated tablet taken once daily

  • DrugFamotidine CT

    Famotidine 20 mg oral chewable tablet taken once daily

06

What researchers measure

Primary outcomes

  1. 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

    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.

    Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

  2. Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water

    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.

    Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

Secondary outcomes

  1. AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water

    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.

    Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

  2. Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water

    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.

    Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

07

Results

Posted Dec 9, 2015

Participant flow

Period I
Participant flow — Period I
MilestoneFCT With Water / CT Without Water / CT With WaterCT Without Water / CT With Water / FCT With WaterCT With Water / FCT With Water / CT Without WaterFCT With Water / CT With Water / CT Without WaterCT Without Water / FCT With Water / CT With WaterCT With Water / CT Without Water / FCT With Water
Started555555
Completed555555
Not completed000000
Period II
Participant flow — Period II
MilestoneFCT With Water / CT Without Water / CT With WaterCT Without Water / CT With Water / FCT With WaterCT With Water / FCT With Water / CT Without WaterFCT With Water / CT With Water / CT Without WaterCT Without Water / FCT With Water / CT With WaterCT With Water / CT Without Water / FCT With Water
Started555555
Completed555555
Not completed000000
Period III
Participant flow — Period III
MilestoneFCT With Water / CT Without Water / CT With WaterCT Without Water / CT With Water / FCT With WaterCT With Water / FCT With Water / CT Without WaterFCT With Water / CT With Water / CT Without WaterCT Without Water / FCT With Water / CT With WaterCT With Water / CT Without Water / FCT With Water
Started555555
Completed555555
Not completed000000

Outcome measures

PrimaryArea 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

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.

Time frame:
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Reported as:
Geometric mean · ng/mL hr
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
ng/mL hrFamotidine 20 mg CT Without WaterFamotidine 20 mg FCT With 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 Water398.5 (350.9 to 452.6)394.8 (347.6 to 448.4)
Statistical analysis
  • Famotidine 20 mg CT Without Water vs Famotidine 20 mg FCT With Water · Geometric mean ratio: 1.01 · 90% CI 0.94 to 1.09
PrimaryPeak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water

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.

Time frame:
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Reported as:
Geometric mean · ng/mL
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
ng/mLFamotidine 20 mg CT Without WaterFamotidine 20 mg FCT With Water
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water67.2 (58.7 to 76.9)65.1 (56.9 to 74.5)
Statistical analysis
  • Famotidine 20 mg CT Without Water vs Famotidine 20 mg FCT With Water · Geometric mean ratio: 1.03 · 90% CI 0.93 to 1.14
SecondaryAUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water

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.

Time frame:
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Reported as:
Geometric mean · ng/mL hr
AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
ng/mL hrFamotidine 20 mg CT With WaterFamotidine 20 mg FCT With Water
AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water440.1 (387.5 to 499.8)394.8 (347.6 to 448.4)
Statistical analysis
  • Famotidine 20 mg CT With Water vs Famotidine 20 mg FCT With Water · Geometric mean ratio: 1.11 · 90% CI 1.04 to 1.20
SecondaryCmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water

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.

Time frame:
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Reported as:
Geometric mean · ng/mL
Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
ng/mLFamotidine 20 mg CT With WaterFamotidine 20 mg FCT With Water
Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water73.0 (63.8 to 83.6)65.1 (56.9 to 74.5)
Statistical analysis
  • Famotidine 20 mg CT With Water vs Famotidine 20 mg FCT With Water · Geometric mean ratio: 1.12 · 90% CI 1.02 to 1.24

Adverse events

Collected over Up to 31 days (including 14 day follow-up). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Famotidine 20 mg FCT With Water—0/30 (0%)4/30 (13.3%)
Famotidine 20 mg CT Without Water—0/30 (0%)3/30 (10%)
Famotidine 20 mg CT With Water—0/30 (0%)4/30 (13.3%)
Most frequent other events
Most frequent other events
EventFamotidine 20 mg FCT With WaterFamotidine 20 mg CT Without WaterFamotidine 20 mg CT With Water
HeadacheNervous system disorders3/303/303/30
DizzinessNervous system disorders0/301/300/30
RhinitisRespiratory, thoracic and mediastinal disorders0/300/301/30
Syncope vasovagalVascular disorders1/300/300/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)FCT With Water / CT Without Water / CT With WaterCT Without Water / CT With Water / FCT With WaterCT With Water / FCT With Water / CT Without WaterFCT With Water / CT With Water / CT Without WaterCT Without Water / FCT With Water / CT With WaterCT With Water / CT Without Water / FCT With WaterTotal
Mean32.4 ± 5.3224.0 ± 7.3824.2 ± 4.3822.6 ± 3.5126.4 ± 6.1125.6 ± 6.5025.9 ± 6.09
Sex: Female, Male
Sex: Female, Male(Participants)FCT With Water / CT Without Water / CT With WaterCT Without Water / CT With Water / FCT With WaterCT With Water / FCT With Water / CT Without WaterFCT With Water / CT With Water / CT Without WaterCT Without Water / FCT With Water / CT With WaterCT With Water / CT Without Water / FCT With WaterTotal
Female42024214
Male13531316
Weight
Weight(Pounds)FCT With Water / CT Without Water / CT With WaterCT Without Water / CT With Water / FCT With WaterCT With Water / FCT With Water / CT Without WaterFCT With Water / CT With Water / CT Without WaterCT Without Water / FCT With Water / CT With WaterCT With Water / CT Without Water / FCT With WaterTotal
Mean137.6 (106.9 to 158.4)163.0 (140.6 to 187.1)175.4 (139.6 to 195.0)147.9 (110.9 to 182.2)142.6 (113.9 to 185.1)180.4 (140.6 to 205.9)157.4 (106.9 to 205.9)
08

Study locations

No study locations are listed for this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2006, a primary completion of Sep 2006 and a completion of Sep 2006. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2015, 9 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2009
First posted
Jul 24, 2009
Start
Aug 2006
Primary completionActual
Sep 2006
CompletionActual
Sep 2006
Results first posted
Dec 9, 2015
Last update
Mar 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00945750
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jul 24, 2009
Start date
Aug 2006
Primary completion
Sep 2006
Completion
Sep 2006
Results posted
Dec 9, 2015
Last update
Mar 10, 2017

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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