HealthyPhase 1NCT01511731
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
A Phase 1 study testing Famotidine and Pepcid in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
Trial summary
The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck \&Co, pepcid 40 mg famotidine tablets under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Famotidine and Pepcid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 1998to Oct 1998
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- History or presence of significant:
- cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- In addition, history or presence of:
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- Subjects who, through completion of the study, would have donated in excess of:
Show all 13Show fewer
- 500 mL of blood in 14 days, or
- 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
- 1000 mL of blood in 90 days,
- 1250 mL of blood in 120 days,
- 1500 mL of blood in 180 days,
- 2000 mL of blood in 270 days,
- 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Randomized, 2-way Crossover Study to Compare the Bioavailability of Reddy Cheminor and Merck &Co, Pepcid Famotidine Tablets 40 mg Under Fasting Conditions.
The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck \&Co, pepcid 40 mg famotidine tablets under fasting conditions.
Read the detailed description
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.
- Conditions
- Healthy
- Being tested
- Famotidine, Pepcid
- Keywords
- Bioequivalence, famotidine, Crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamotidineDrug
Also called Reddy Cheminor
Famotidine Tablets 40 mg
PepcidDrug
Also called Merck & Co.
40mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Famotidine | Experimental | Famotidine tablets 40 mg of Dr. Reddy's Receives: Drug: Famotidine |
| Pepcid | Active comparator | Pepcid 40 mg Tablets of Merck \& Co., Receives: Drug: Pepcid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
Measured: predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 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.
- First posted19 Jan 2012 (estimated)
- Study startOct 1998
- Primary completionOct 1998
- Study completionOct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Serfaty, MD, Principal investigator, Phoenix Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511731
- Sponsor's protocol ID
- 981325
- Status last verified
- Jan 2012
- First submitted
- 12 Jan 2012
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, 2-way Crossover Study to Compare the Bioavailability of Reddy Cheminor and Merck &Co, Pepcid Famotidine Tablets 40 mg Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01511731
- Acronym / sponsor ID
- 981325
- Conditions
- Healthy
- Keywords
- Bioequivalence, famotidine, Crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Oct 1998 (actual)
- Study completion
- Oct 1998 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck \&Co, pepcid 40 mg famotidine tablets under fasting conditions.
Detailed description
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Famotidine | Experimental | Drug: FamotidineFamotidine tablets 40 mg of Dr. Reddy's |
| Pepcid | Active comparator | Drug: PepcidPepcid 40 mg Tablets of Merck \& Co., |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- alcoholism or drug abuse within the past year;
- hypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- 500 mL of blood in 14 days, or
- 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
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 |
|---|---|---|
| FamotidineAlso: Reddy CheminorFamotidine Tablets 40 mg | Drug | Famotidine |
| PepcidAlso: Merck & Co.40mg tablets | Drug | Pepcid |
Primary outcome
Area Under Curve (AUC)
Time frame: predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
Samuel Serfaty, MD principal investigator
Phoenix Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Famotidine and Pepcid in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
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 0 inclusion and 13 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 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Curve (AUC) (time frame: predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2012.