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A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta

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ClinicalTrials.gov Identifier: NCT03729284
Recruitment Status : Withdrawn (This study has been cancelled prior to FSFV due to business reasons)
First Posted : November 2, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Cymbalta Capsules Drug: Duloxetine Hydrochloride Capsules Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : March 30, 2020
Estimated Primary Completion Date : June 7, 2020
Estimated Study Completion Date : June 7, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duloxetine Hydrochloride
Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2
Drug: Duloxetine Hydrochloride Capsules
Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.
Other Name: Test Drug

Active Comparator: Cymbalta
Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2
Drug: Cymbalta Capsules
Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.
Other Name: Reference Drug




Primary Outcome Measures :
  1. 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)

  2. Maximum plasma concentrations (Cmax) [ Time Frame: Up to 72 hours post dose ]

Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [ Time Frame: Up to 72 hours post dose ]
  2. Time to first occurrence of Cmax (Tmax) [ Time Frame: Up to 72 hours post dose ]
  3. Terminal phase rate constant (kel) [ Time Frame: Up to 72 hours post dose ]
  4. 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 ]
    Following parameters will be analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse rate, and axillary temperature.

  5. 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 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729284


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03729284    
Other Study ID Numbers: B2781004
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents