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HealthyPhase 1NCT01910090

Bioequivalence Study of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET in Healthy Subjects Under Fasting Conditions

A Phase 1 study testing FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET and ANTADYS® 100 mg, PEPCID® 20 mg in people with Healthy, run by Pharmaceutical Research Unit, Jordan at 1 site in Jordan.

Completed

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

Official record
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Trial summary

To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé \& PEPCID® (Famotidine) 20mg Tablets, USP. 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?
FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET and ANTADYS® 100 mg, PEPCID® 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteJordan
Study dates
Dec 2012to Jan 2013
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

  • Healthy Male subjects.
  • Ethnic Group: Arab \& Mediterranean
  • Race: Mixed skin (white \& black skin people).
  • Age 18-45 years
  • Body-mass index 18.5 to 30.0 kg/m2 inclusive
  • Subject is available for the whole study period and gave written informed consent
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  • Physical examination within normal ranges
  • All laboratory screening results within the normal range, or being assessed as clinically non-significant by the attending physician.
  • Vital signs within normal ranges (Unless clinical investigator classified as insignificant).
  • Normal Kidney \& Liver function tests (Unless clinical investigator classified as insignificant).
  • Normal Cardiovascular system.
  • Normal Digestive system.

Who cannot join

  • Women.
  • Ethnic Group (Non- Arab \&/ or Non- Mediterranean)
  • History of severe allergy or allergic reactions to study drug or related drugs
  • Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • History of serious illness that can impact fate of drugs
  • Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate
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  • Clinically significant illness 4 weeks before study Period I
  • Mental disease, drug, alcohol, solvents or caffeine abuse, smoking.
  • Regular use of medication
  • Having taken medication that could affect the investigated drug product: a) Regular consumption of drugs during the two weeks prior to study initiation day, b) consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates, Carbamazepine, Phenytoin) during one month before the study initiation.
  • Presence of any significant physical or organ abnormality
  • Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
  • Participation in another bioequivalence study within 80 days prior to the start of this study Period I
  • Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
  • History of Gastrointestinal diseases
  • Prior history of hypersensitivity to Flurbiprofen or Famotidine and other competitive inhibitor of histamine H2-receptors.
  • Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
  • Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
  • Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
  • Any significant clinical abnormality including HBsAg, HCV, and HIV
  • Abnormal vital signs
  • Abnormal Kidney or Liver function tests.
  • Abnormal Cardiovascular system.
  • Abnormal Digestive system
  • Vomiting, Diarrhea.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit

    Amman, 00962

Other trials in Jordan

About this study

Official title: Comparative, Randomized, Two-period, Two-treatment, Two-sequence, Single Dose, Open-label, Crossover Bioequivalence Study of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET (One Tablet) of (Sanovel İlaç San. ve Tic. A.Ş., İstanbul / Türkiye) Versus ANTADYS® Flurbiprofen 100 mg Comprimé Pelliculé (One Film-coated Tablet) of (LaboratoireThẻramex 6, Avenue Albert II- BP.59 98007 MONACO Cedex) and PEPCID® (Famotidine) 20 mg Tablets, USP (One Tablet) of (Marathon Pharmaceuticals, LLC USA) in Healthy Subjects Under Fasting Conditions

To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé \& PEPCID® (Famotidine) 20mg Tablets, USP.

Read the detailed description

An open-label, randomized, single dose, two-treatment, two-period, two-sequence, crossover bioequivalence with a washout period of at least 7 days between doses Healthy mixed skin Arab \& Mediterranean Subjects ages between 18 and 45 years, body-mass index 18.5 to 30.0 kg/m2 inclusive, non-smokers or light smokers (smokers of not more than 10 cigarettes per day).

Conditions
Healthy
Being tested
FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET, ANTADYS® 100 mg, PEPCID® 20 mg
Keywords
fasting condition

What participants receive

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

  • FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLETDrug

    Also called MULTI-LAYER TABLET

    MULTI-LAYER TABLET

  • ANTADYS® 100 mg, PEPCID® 20 mgDrug

    Also called ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once

    ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once

Study groups in NCT01910090
Study groupRoleWhat they receive
FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLETExperimentalFLURBIPROFEN, FAMOTIDINE 100/20 mg MULTI-LAYER TABLET one tablet, once
Receives: Drug: FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET
ANTADYS® and PEPCID®Active comparatorANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once
Receives: Drug: ANTADYS® 100 mg, PEPCID® 20 mg

What is being measured

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

  1. cmax

    Cmax Ratio: The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on Flurbiprofen and Famotidine.

    AUC Ratio: The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on Flurbiprofen and Famotidine.

    Measured: five weeks

  2. tmax

    Measured: three weeks

Timeline

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

  1. First posted29 Jul 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01910090
Sponsor's protocol ID
FAFL439/PRO-00
Status last verified
Dec 2012
First submitted
15 Dec 2012
Last updated
29 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET and ANTADYS® 100 mg, PEPCID® 20 mg in people with Healthy, run by Pharmaceutical Research Unit, Jordan at 1 site in Jordan.

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 12 inclusion and 25 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 29 Jul 2013. 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 Jordan. 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?

cmax (time frame: five weeks). 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 NCT01910090.

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 29 Jul 2013.

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