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

NCT03794154 | Withdrawn Phase 4

• 1 other identifier: B2781005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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)

  Upto 72 hours post dose

• Maximum plasma concentration (Cmax)

  Upto 72 hours post dose

Secondary Outcomes (3)

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time

  Upto 72 hours post dose

• Time to first occurrence of Cmax (Tmax)

  Upto 72 hours post dose

• Terminal phase rate constant (kel)

  Upto 72 hours post dose

Study Arms (2)

Duloxetine hydrochloride

EXPERIMENTAL

Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2

Drug: Duloxetine hydrochloride capsule

Cymbalta

ACTIVE COMPARATOR

Duloxetine hydrochloride hard gelatinous capsule 60 mg as Cymbalta by mouth on Day 1 of period 1 or 2

Drug: Cymbalta capsule

Interventions

Cymbalta capsule DRUG

Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.

Also known as: Reference drug

Cymbalta

Duloxetine hydrochloride capsule DRUG

Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.

Also known as: Test drug

Duloxetine hydrochloride

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Duloxetine Hydrochloride; Drug Evaluation

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 4, 2019
• Study Start: March 30, 2020
• Primary Completion: June 5, 2020
• Study Completion: June 5, 2020
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share