HealthyPhase 4NCT03803371

Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets

A Phase 4 study testing Ultracet Tablets and Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer) in people with Healthy, run by Pfizer at 1 site in Brazil.

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ultracet Tablets and Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteBrazil
Study dates: 26 Mar 2019to 28 Jun 2019
Phase: Phase 4
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy female research subjects and/or male research subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
Have undergone a documented hysterectomy and/or bilateral oophorectomy;
Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
2. Body mass index (BMI) of 18.5 kg/m2 to 24.9 kg/m2 (the upper limit may vary up to 15% to allow subjects with a BMI from 18.5 kg/m2 to 28.6 kg/m2 to participate), and a total body weight >50 kg (>110 lbs).
3. Evidence of a personally signed and dated informed consent document indicating that the research subject has been informed of all pertinent aspects of the study.
4. Research subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Clinically significant infections within the past 3 months (eg, those requiring hospitalization or parenteral antibiotics, or as judged by the Investigator), evidence of any infection within the past 7 days, history of disseminated herpes simplex infection or recurrent or disseminated herpes zoster.
Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection, etc.).
Research subjects with a history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic).
History of or current positive results for any of the following serological tests: hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), anti hepatitis C core antibody (HCV Ab), or human immunodeficiency virus (HIV) 1 and 2.
Malignancy or a history of malignancy

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A positive urine drug test.
A positive alcohol screen.
History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months before screening.
Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
Treatment with an investigational drug within 6 months or 4 or 5 half lives preceding the first dose of investigational product (whichever is longer).
Pregnant female subjects, breastfeeding female subjects, fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol from at least 14 days prior to the first dose of investigational product until at least 28 days after the last dose of investigational product.
Use of prescription or nonprescription drugs and dietary supplements within 14 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. Limited use of non prescription medications that are not believed to affect research subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor.
Herbal supplements, hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone releasing intrauterine devices [IUDs], vaginal ring, and postcoital contraceptive methods), and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product.
Consumption of grapefruit or grapefruit related citrus fruits (eg, Seville oranges, pomelos) or juices within 7 days prior to dosing.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 3 months prior to screening.
History of sensitivity to heparin or heparin induced thrombocytopenia.
History of hypersensitivity to tramadol or paracetamol or any of the components in the formulation of the study products.
Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the research subject inappropriate for entry into this study.
Research subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or research subjects who are the sponsor's employees, including their family members, directly involved in the conduct of the study.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

ICF - Instituto de Ciencias Farmaceuticas de Estudos e Pesquisas Ltda
Aparecida de Goiânia, Goiás, 74935-530

Other trials in Brazil

About this study

Official title: A PHASE IV, OPEN LABEL, RANDOMIZED, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, CROSSOVER BIOEQUIVALENCE STUDY TO COMPARE AN ORAL FORMULATION OF TRAMADOL HYDROCHLORIDE 37.5 MG/PARACETAMOL 325 MG TABLETS (TEST PRODUCT OF PFIZER) VERSUS ULTRACET(REGISTERED) (TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5 MG/325 MG OF JANSSEN CILAG FARMACÊUTICA LTDA, REFERENCE PRODUCT OF BRAZIL) IN HEALTHY ADULT RESEARCH SUBJECTS UNDER FASTING CONDITIONS

The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®. In order to meet the requirements for registration as a generic drug, this study is being conducted to demonstrate the bioequivalence between the formulation of tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg provided by Pfizer and the reference drug tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg, available in the pharmaceutical market in Brazil (Ultracet®, Janssen Cilag Farmacêutica Ltda).

Conditions: Healthy
Being tested: Ultracet Tablets, Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)

What participants receive

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

Ultracet TabletsDrug
Also called Reference drug
Ultracet tablet (Janssen Cilag Farmacêutica Ltda) equivalent to Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg
Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)Drug
Also called Test Drug
Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets (Pfizer)

Study groups in NCT03803371
Study group	Role	What they receive
Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets	Experimental	Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets by mouth on Day 1 of period 1 or 2 Receives: Drug: Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)
Ultracet tablet	Active comparator	Ultracet tablet (Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg) by mouth on Day 1 of period 1 or 2 Receives: Drug: Ultracet Tablets

What is being measured

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

Area under the tramadol and paracetamol plasma concentration-time curve from time zero to last time point (AUClast)
Measured: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose
Maximum plasma concentrations of tramadol and paracetamol (Cmax)
Measured: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose

Secondary outcomes (3)

Area under the tramadol and paracetamol plasma concentration-time curve from time zero extrapolated to infinite time
Measured: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose
Time to first occurrence of Cmax (Tmax) of tramadol and paracetamol
Measured: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose

Timeline

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

26 Mar 201928 Jun 2019

First posted14 Jan 2019
Study start26 Mar 2019
Primary completion28 Jun 2019
Study completion28 Jun 2019

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.
More trials run by PfizerThe 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03803371
Sponsor's protocol ID: B4741005
Status last verified: Jul 2019
First submitted: 2 Jan 2019
Last updated: 17 Jul 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE IV, OPEN LABEL, RANDOMIZED, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, CROSSOVER BIOEQUIVALENCE STUDY TO COMPARE AN ORAL FORMULATION OF TRAMADOL HYDROCHLORIDE 37.5 MG/PARACETAMOL 325 MG TABLETS (TEST PRODUCT OF PFIZER) VERSUS ULTRACET(REGISTERED) (TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5 MG/325 MG OF JANSSEN CILAG FARMACÊUTICA LTDA, REFERENCE PRODUCT OF BRAZIL) IN HEALTHY ADULT RESEARCH SUBJECTS UNDER FASTING CONDITIONS
ClinicalTrials.gov ID: NCT03803371
Acronym / sponsor ID: B4741005
Conditions: Healthy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 26 Mar 2019 (actual)
Primary completion: 28 Jun 2019 (actual)
Study completion: 28 Jun 2019 (actual)
First posted: 14 Jan 2019 (actual)
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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets	Experimental	Drug: Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets by mouth on Day 1 of period 1 or 2
Ultracet tablet	Active comparator	Drug: Ultracet TabletsUltracet tablet (Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg) by mouth on Day 1 of period 1 or 2

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

1. Healthy female research subjects and/or male research subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
Have undergone a documented hysterectomy and/or bilateral oophorectomy;
Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.

Key exclusion criteria (21 listed)

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
Ultracet TabletsAlso: Reference drugUltracet tablet (Janssen Cilag Farmacêutica Ltda) equivalent to Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg	Drug	Ultracet tablet
Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)Also: Test DrugTramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets (Pfizer)	Drug	Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets

Primary outcome

Area under the tramadol and paracetamol plasma concentration-time curve from time zero to last time point (AUClast)
Time frame: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose
Maximum plasma concentrations of tramadol and paracetamol (Cmax)
Time frame: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose

3 secondary outcomes

Area under the tramadol and paracetamol plasma concentration-time curve from time zero extrapolated to infinite time
Time frame: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose
Time to first occurrence of Cmax (Tmax) of tramadol and paracetamol
Time frame: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 hours post dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 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 17 Jul 2019.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ultracet Tablets and Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer) in people with Healthy, run by Pfizer at 1 site in Brazil.

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 8 inclusion and 21 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 17 Jul 2019. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 the tramadol and paracetamol plasma concentration-time curve from time zero to last time point (AUClast) (time frame: Predose (0 hour), at 0.08, 0.16, 0.25, 0.33, 0.41, 0.50, 0.66, 0.83, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12, 24 and 36 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 NCT03803371.

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 17 Jul 2019.