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 range

18 Years – 55 Years

Sex

MALE

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Healthy trials