HealthyPhase 4NCT03729284
A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta
A Phase 4 study testing Cymbalta Capsules and Duloxetine Hydrochloride Capsules in people with Healthy, run by Pfizer.
Trial summary
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®), respectively. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cymbalta Capsules and Duloxetine Hydrochloride Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2020to 7 Jun 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male research subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Body mass index (BMI) of 18.5 kg/m2 to 24.9 kg/m2, and a total body weight >50 kg (>110 lbs).
- 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.
- Research subjects that never smoked.
- 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.
- Clinically significant infections within the past 3 months, evidence of any infection within the past 7 days, history of disseminated herpes simplex infection or recurrent (>1 episode) or disseminated herpes zoster.
- Vaccination with live or attenuated vaccines within 6 weeks prior to dosing.
- A history of suicidal thoughts, behavior or suicide attempts.
- History of narrow angle glaucoma.
- Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection, etc.).
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- 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.
- A positive urine drug test.
- A positive alcohol screen.
- History of regular alcohol consumption exceeding 21 drinks/week for male research 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 all nicotine containing products.
- Treatment with an investigational drug within 6 months or 5 half lives preceding the first dose of investigational product (whichever is longer).
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 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.
- 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 until collection of the final PK blood sample (Period 2, Day 4).
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- History of hypersensitivity to duloxetine 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.
- Use of any medicinal product that is an inductor or strong inhibitor of CYP450 1A2 or 2D6 (eg, rifampicin, omeprazole, fluvoxamine, ciprofloxacin, fluoxetine, paroxetine, etc) within two weeks before administration of the investigational product and at any time during the study.
- Use of any medicinal product that inhibits monoamine oxidase A or B (eg, phenelzine, isocarboxacid, linezolid) within two weeks before administration of the investigational product and at any time during the study till at least 5 days after the last dose of investigational product.
About this study
Official title: A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA) COMPARED WITH CYMBALTA(REGISTERED) ( 60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FASTED CONDITIONS
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®), respectively.
The Sponsor has developed a hard gelatinous capsule with delayed release microgranules formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30, or 60 mg of duloxetine, respectively.
The purpose of this study is to verify through a single dose study, if the test formulation of duloxetine (60 mg) is bioequivalent to the reference formulation (Cymbalta® 60 mg) when administered with the same dosage and under fasted conditions in healthy male research subjects.
- Conditions
- Healthy
- Being tested
- Cymbalta Capsules, Duloxetine Hydrochloride Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cymbalta CapsulesDrug
Also called Reference Drug
Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.
Duloxetine Hydrochloride CapsulesDrug
Also called Test Drug
Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine Hydrochloride | Experimental | Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2 Receives: Drug: Duloxetine Hydrochloride Capsules |
| Cymbalta | Active comparator | Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2 Receives: Drug: Cymbalta Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Measured: Up to 72 hours post dose
Maximum plasma concentrations (Cmax)
Measured: Up to 72 hours post dose
Secondary outcomes (5)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time
Measured: Up to 72 hours post dose
Time to first occurrence of Cmax (Tmax)
Measured: Up to 72 hours post dose
Terminal phase rate constant (kel)
Measured: Up to 72 hours post dose
Number Of Participants with Clinically Significant Change From Baseline In Vital Signs
Following parameters will be analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse rate, and axillary temperature.
Measured: Baseline up to Day 28 after last dose of drug administration
Number Of Participants With Clinically Significant Change From Baseline in Laboratory Tests
Pre-defined criteria will be established to identify the values of potential clinical importance for the following laboratory tests: hematology, serum chemistry, and urinalysis, and electrocardiograms (ECG).
Measured: Baseline up to Day 28 after last dose of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start30 Mar 2020 (estimated)
- Primary completion7 Jun 2020 (estimated)
- Study completion7 Jun 2020 (estimated)
Why it stopped: This study has been cancelled prior to FSFV due to business reasons
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729284
- Sponsor's protocol ID
- B2781004
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2018
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA) COMPARED WITH CYMBALTA(REGISTERED) ( 60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FASTED CONDITIONS
- ClinicalTrials.gov ID
- NCT03729284
- Acronym / sponsor ID
- B2781004
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been cancelled prior to FSFV due to business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2020 (estimated)
- Primary completion
- 7 Jun 2020 (estimated)
- Study completion
- 7 Jun 2020 (estimated)
- First posted
- 2 Nov 2018 (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.
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®), respectively.
The Sponsor has developed a hard gelatinous capsule with delayed release microgranules formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30, or 60 mg of duloxetine, respectively.
The purpose of this study is to verify through a single dose study, if the test formulation of duloxetine (60 mg) is bioequivalent to the reference formulation (Cymbalta® 60 mg) when administered with the same dosage and under fasted conditions in healthy male research subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine Hydrochloride | Experimental | Drug: Duloxetine Hydrochloride CapsulesDuloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2 |
| Cymbalta | Active comparator | Drug: Cymbalta CapsulesDuloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male research subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Body mass index (BMI) of 18.5 kg/m2 to 24.9 kg/m2, and a total body weight >50 kg (>110 lbs).
- 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.
- Research subjects that never smoked.
- Research subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (22 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Clinically significant infections within the past 3 months, evidence of any infection within the past 7 days, history of disseminated herpes simplex infection or recurrent (>1 episode) or disseminated herpes zoster.
- Vaccination with live or attenuated vaccines within 6 weeks prior to dosing.
- A history of suicidal thoughts, behavior or suicide attempts.
- History of narrow angle glaucoma.
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 |
|---|---|---|
| Cymbalta CapsulesAlso: Reference DrugActive Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine. | Drug | Cymbalta |
| Duloxetine Hydrochloride CapsulesAlso: Test DrugExperimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine. | Drug | Duloxetine Hydrochloride |
Primary outcome
Area under the plasma concentration-time curve
Time frame: Up to 72 hours post dose
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Maximum plasma concentrations (Cmax)
Time frame: Up to 72 hours post dose
5 secondary outcomes
Area under the plasma concentration-time curve from time zero extrapolated to infinite time
Time frame: Up to 72 hours post dose
Time to first occurrence of Cmax (Tmax)
Time frame: Up to 72 hours post dose
Terminal phase rate constant (kel)
Time frame: Up to 72 hours post dose
Number Of Participants with Clinically Significant Change From Baseline In Vital Signs
Time frame: Baseline up to Day 28 after last dose of drug administration
Number Of Participants With Clinically Significant Change From Baseline in Laboratory Tests
Time frame: Baseline up to Day 28 after last dose of drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cymbalta Capsules and Duloxetine Hydrochloride Capsules in people with Healthy, run by Pfizer.
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 5 inclusion and 22 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: withdrawn, as of the sponsor's last update on 4 Oct 2019. 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 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 was withdrawn before enrolling participants, so there are no results.
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 plasma concentration-time curve (time frame: Up to 72 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?
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 4 Oct 2019.