A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions
NCT03794154
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- 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.
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions | ||||||
Official Title ICMJE | 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 TO CYMBALTA (REGISTERED) MICROGRANULES (60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FED CONDITIONS | ||||||
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 is bioequivalent to the reference formulation (Cymbalta®) when administered with the same dosage and under fed conditions in healthy male research subjects. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Other | ||||||
Condition ICMJE | Healthy | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Withdrawn | ||||||
Actual Enrollment ICMJE | 0 | ||||||
Original Estimated Enrollment ICMJE | 48 | ||||||
Estimated Study Completion Date ICMJE | June 5, 2020 | ||||||
Estimated Primary Completion Date | June 5, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03794154 | ||||||
Other Study ID Numbers ICMJE | B2781005 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | September 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |