You are here

Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets

Last updated on November 16, 2018

FOR MORE INFORMATION
Study Location
ICF - Instituto de Ciencias Farmaceuticas de Estudos e Pesquisas Ltda
Aparecida de Goiania, GO, 74935-530 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
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 female research subjects and/or male research subjects who, at the time of
screening, are between the ages of 18 and 55 years, inclusive.

- Female research subjects of non-childbearing potential

- 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 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.

- Evidence or history of cyclic neutropenia.

- Personal or family history of hereditary immunodeficiency (eg, severe combined
immunodeficiency disorder [SCID], Wiskott Aldrich syndrome, X linked
agammaglobulinemia).

- Vaccination with live or attenuated vaccines within 6 weeks prior to dosing, or is to
be vaccinated with these vaccines at any time during treatment or within 6 weeks
following discontinuation of dosing.

- Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection,
etc.).

- Research subjects with a history of, or current evidence for, severe gastrointestinal
narrowing (pathologic or iatrogenic).

- 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.

- A positive urine drug test.

- A positive alcohol screen.

- History of regular alcohol consumption exceeding 14 drinks/week for female research
subjects or 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 nicotine containing products in excess of the equivalent of 5
cigarettes per day. For chewing tobacco, one chew is equivalent to approximately 2 3
cigarettes, so research subjects would be limited to 2 or less chews per day.

- Treatment with an investigational drug within 6 months or 5 half lives preceding the
first dose of investigational product (whichever is longer).

- Pregnant female research subjects, breastfeeding female research subjects, fertile
male research subjects and female research subjects of childbearing potential who are
unwilling or unable to use a highly effective method of contraception as outlined in
this protocol from at least 14 days prior to the first dose of investigational product
until at least 28 days after the last dose of investigational product.

- A positive beta human chorionic gonadotropin test for women of childbearing potential.

- 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.

- Herbal supplements, hormonal methods of contraception (including oral and transdermal
contraceptives, injectable progesterone, progestin subdermal implants, progesterone
releasing intrauterine devices [IUDs], vaginal ring, and postcoital contraceptive
methods), and hormone replacement therapy must have been discontinued at least 28 days
prior to the first dose of investigational product.

- Depo Provera must have been discontinued at least 6 months 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.

- History of sensitivity to heparin or heparin induced thrombocytopenia.

- History of hypersensitivity to sertraline 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.

- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the research subject inappropriate for entry
into this study.

- Research subjects who are investigator site staff members directly involved in the
conduct of the study and their family members, site staff members otherwise supervised
by the investigator, or research subjects who are the sponsor's employees, including
their family members, directly involved in the conduct of the study.

NCT03711708
Pfizer
Recruiting
Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets

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
Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets
A Phase IV, Single-dose, Open-label, Randomized, 2-way Crossover Study To Determine The Relative Bioavailability Of Zoloft (Registered) Oral Solution (20 Mg/ml; Farmasierra Manufacturing, S.l.) Compared To Zoloft (Registered) Tablets (50 Mg; Wyeth Indústria Farmacêutica Ltda.) In Healthy Research Subjects Under Fasted Conditions

In Brazil, sertraline is currently available as film coated tablets for oral administration containing sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline.

The sponsor has developed an oral solution formulation containing 20 mg/mL of sertraline, which must be diluted with 120 mL of water, ginger ale, lime/lemon soda or orange juice to be palatable before use. The purpose of this study is to evaluate the relative bioavailability of Zoloft oral solution compared to Zoloft tablets in healthy participants under fasted conditions.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Healthy
  • Drug: Zoloft Oral Solution
    Test Product: 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water
  • Drug: Zoloft tablets
    Reference Product: 50 mg sertraline administered as 1x Zoloft 50 mg tablet
  • Experimental: Zoloft Oral Solution
    50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water.
    Intervention: Drug: Zoloft Oral Solution
  • Active Comparator: Zoloft Tablets
    Zoloft 50 mg tablet.
    Intervention: Drug: Zoloft tablets
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
36
Same as current
February 7, 2019
January 10, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy female research subjects and/or male research subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
  • Female research subjects of non-childbearing potential
  • 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 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.
  • Evidence or history of cyclic neutropenia.
  • Personal or family history of hereditary immunodeficiency (eg, severe combined immunodeficiency disorder [SCID], Wiskott Aldrich syndrome, X linked agammaglobulinemia).
  • Vaccination with live or attenuated vaccines within 6 weeks prior to dosing, or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of dosing.
  • Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection, etc.).
  • Research subjects with a history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic).
  • 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.
  • A positive urine drug test.
  • A positive alcohol screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for female research subjects or 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 nicotine containing products in excess of the equivalent of 5 cigarettes per day. For chewing tobacco, one chew is equivalent to approximately 2 3 cigarettes, so research subjects would be limited to 2 or less chews per day.
  • Treatment with an investigational drug within 6 months or 5 half lives preceding the first dose of investigational product (whichever is longer).
  • Pregnant female research subjects, breastfeeding female research subjects, fertile male research subjects and female research subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol from at least 14 days prior to the first dose of investigational product until at least 28 days after the last dose of investigational product.
  • A positive beta human chorionic gonadotropin test for women of childbearing potential.
  • 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.
  • Herbal supplements, hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone releasing intrauterine devices [IUDs], vaginal ring, and postcoital contraceptive methods), and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product.
  • Depo Provera must have been discontinued at least 6 months 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.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
  • History of hypersensitivity to sertraline 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.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the research subject inappropriate for entry into this study.
  • Research subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or research subjects who are the sponsor's employees, including their family members, directly involved in the conduct of the study.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Brazil
 
 
NCT03711708
A0501107
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
October 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