HeartburnPhase 1NCT00945750

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

A Phase 1 study testing Famotidine FCT and Famotidine CT in people with Heartburn, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Heartburn
What is being tested?: Famotidine FCT and Famotidine CT
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Aug 2006to Sep 2006
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Female participant is not pregnant or lactating
Female of childbearing potential must use reliable means of contraception 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

Who cannot join

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

Show all 11Show fewer

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 investigational 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 contraception

About this study

Official title: A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets (FCT) Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg Chewable Tablets (CTw) With Water (Protocol 144)

Conditions: Heartburn
Being tested: Famotidine FCT, Famotidine CT
Medical subject headings: Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Famotidine FCTDrug
Famotidine 20 mg oral film-coated tablet taken once daily
Famotidine CTDrug
Famotidine 20 mg oral chewable tablet taken once daily

Study groups in NCT00945750
Study group	Role	What they receive
Sequence 1: FCT with water → CT without water → CT with water	Experimental	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). Receives: Drug: Famotidine FCT; Drug: Famotidine CT
Sequence 2: CT without water → CT with water → FCT with water	Experimental	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). Receives: Drug: Famotidine FCT; Drug: Famotidine CT
Sequence 3: CT with water → FCT with water → CT without water	Experimental	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). Receives: Drug: Famotidine FCT; Drug: Famotidine CT
Sequence 4: FCT with water → CT with water → CT without water	Experimental	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). Receives: Drug: Famotidine FCT; Drug: Famotidine CT
Sequence 5: CT without water → FCT with water → CT with water	Experimental	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). Receives: Drug: Famotidine FCT; Drug: Famotidine CT
Sequence 6: CT with water → CT without water → FCT with water	Experimental	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). Receives: Drug: Famotidine FCT; Drug: Famotidine CT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Sep 2006

First posted24 Jul 2009 (estimated)
Study startAug 2006
Primary completionSep 2006
Study completionSep 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HeartburnStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00945750
Sponsor's protocol ID: 0208-144
Other IDs: 2009_621
Status last verified: Jan 2017
First submitted: 22 Jul 2009
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia

All Heartburn trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets (FCT) Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg Chewable Tablets (CTw) With Water (Protocol 144)
ClinicalTrials.gov ID: NCT00945750
Acronym / sponsor ID: 0208-144
Conditions: Heartburn
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Sep 2006 (actual)
Study completion: Sep 2006 (actual)
First posted: 24 Jul 2009 (estimated)
Results: Posted 9 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1: FCT with water → CT without water → CT with water	Experimental	Drug: Famotidine FCT, Drug: Famotidine CTParticipants 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).
Sequence 2: CT without water → CT with water → FCT with water	Experimental	Drug: Famotidine FCT, Drug: Famotidine CTParticipants 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).
Sequence 3: CT with water → FCT with water → CT without water	Experimental	Drug: Famotidine FCT, Drug: Famotidine CTParticipants 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).
Sequence 4: FCT with water → CT with water → CT without water	Experimental	Drug: Famotidine FCT, Drug: Famotidine CTParticipants 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).
Sequence 5: CT without water → FCT with water → CT with water	Experimental	Drug: Famotidine FCT, Drug: Famotidine CTParticipants 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).
Sequence 6: CT with water → CT without water → FCT with water	Experimental	Drug: Famotidine FCT, Drug: Famotidine CTParticipants 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).

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Female participant is not pregnant or lactating
Female of childbearing potential must use reliable means of contraception 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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Famotidine FCTFamotidine 20 mg oral film-coated tablet taken once daily	Drug	Sequence 1: FCT with water → CT without water → CT with water, Sequence 2: CT without water → CT with water → FCT with water, Sequence 3: CT with water → FCT with water → CT without water, Sequence 4: FCT with water → CT with water → CT without water, Sequence 5: CT without water → FCT with water → CT with water, Sequence 6: CT with water → CT without water → FCT with water
Famotidine CTFamotidine 20 mg oral chewable tablet taken once daily	Drug	Sequence 1: FCT with water → CT without water → CT with water, Sequence 2: CT without water → CT with water → FCT with water, Sequence 3: CT with water → FCT with water → CT without water, Sequence 4: FCT with water → CT with water → CT without water, Sequence 5: CT without water → FCT with water → CT with water, Sequence 6: CT with water → CT without water → FCT with water

Primary outcome

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
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
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.
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
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.

2 secondary outcomes

AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose

Results and safety

Results posted to the registry on 9 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FCT With Water / CT Without Water / CT With Water	5	5
CT Without Water / CT With Water / FCT With Water	5	5
CT With Water / FCT With Water / CT Without Water	5	5
FCT With Water / CT With Water / CT Without Water	5	5
CT Without Water / FCT With Water / CT With Water	5	5
CT With Water / CT Without Water / FCT With Water	5	5

Primary outcome: 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

Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose. Geometric mean (95% Confidence Interval). Unit: ng/mL hr

Measure	Famotidine 20 mg CT Without Water n = 30	Famotidine 20 mg FCT With Water n = 30
Value	398.5 (350.9 to 452.6)	394.8 (347.6 to 448.4)

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)

Population analysed: Participants who completed the study

Primary outcome: Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water

Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	Famotidine 20 mg CT Without Water n = 30	Famotidine 20 mg FCT With Water n = 30
Value	67.2 (58.7 to 76.9)	65.1 (56.9 to 74.5)

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)

Population analysed: Participants who completed the study

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 31 days (including 14 day follow-up). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Famotidine 20 mg FCT With Water	0 of 30 (0%)	4 of 30 (13.3%)	Not reported
Famotidine 20 mg CT Without Water	0 of 30 (0%)	3 of 30 (10%)	Not reported
Famotidine 20 mg CT With Water	0 of 30 (0%)	4 of 30 (13.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heartburn

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Famotidine FCT and Famotidine CT in people with Heartburn, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00945750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.