You are here

A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta

Last updated on November 6, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03729284
Pfizer
Not yet recruiting
A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Healthy Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Healthy
NCT03711708
All Genders
18+
Years
Aparecida de Goiania, GO
A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Healthy
  • 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
  • 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
  • Experimental: Duloxetine Hydrochloride
    Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2
    Intervention: Drug: Duloxetine Hydrochloride Capsules
  • Active Comparator: Cymbalta
    Duloxetine hydrochloride hard gelatinous capsule 60 mg by mouth on Day 1 of period 1 or 2
    Intervention: Drug: Cymbalta Capsules
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
48
Same as current
May 5, 2019
May 5, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03729284
B2781004
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now