WithdrawnPhase 4

A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions

Stopped: This study has been cancelled prior to FSFV due to business reasons

0Started 2020-03-30

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 immunodeficienc…

What they're measuring

Area under the plasma concentration-time curve

Timeframe: Upto 72 hours post dose

Maximum plasma concentration (Cmax)

Timeframe: Upto 72 hours post dose

Trial details

NCT IDNCT03794154

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-05