Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets

NCT03711708 | Completed Phase 4

• 1 other identifier: A0501107
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the sertraline plasma concentration-time curve from time zero to last time point (AUClast)

  Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose

• Maximum observed plasma concentration of sertraline (Cmax)

  Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose

Secondary Outcomes (3)

• Time to first occurrence of Cmax (Tmax) of sertraline

  Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose

• Sertraline plasma elimination half life (t½)

  Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Up to 144 hours post dose

Study Arms (2)

Zoloft Oral Solution

EXPERIMENTAL

50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water.

Drug: Zoloft Oral Solution

Zoloft Tablets

ACTIVE COMPARATOR

Zoloft 50 mg tablet.

Drug: Zoloft tablets

Interventions

Zoloft Oral Solution DRUG

Test Product: 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water

Zoloft Oral Solution

Zoloft tablets DRUG

Reference Product: 50 mg sertraline administered as 1x Zoloft 50 mg tablet

Zoloft Tablets

Eligibility Criteria

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

You may qualify if:

• 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.

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.
• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

ICF - Instituto de Ciencias Farmaceuticas de Estudos e Pesquisas Ltda

Aparecida de Goiânia, Goiás, 74935-530, Brazil

Location

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.

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

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: October 1, 2018
• First Posted: October 18, 2018
• Study Start: November 6, 2018
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)