You are here

Our science / Clinical Trials / Find a Trial / NCT01235195

A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions

Back to Search Print Save as PDF Bookmark Trial

NCT01235195

Last updated on December 4, 2019
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive
(Healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).

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, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Any condition possibly affecting drug absorption (eg, gastrectomy)

NCT01235195
Pfizer
Completed
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions

NEED INFO?

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

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 city or zip code to find studies near you.
Advanced Search

Based on your search, you may also be interested in

Hepatic Impairment, Healthy Participants
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
NCT04016077
All Genders
18+
Years
Multiple Sites
Healthy
Study of Single Ascending Doses of PF-07081532 in Healthy Adult Participants
NCT04148209
All Genders
18+
Years
Brussels,
HEALTHY
Study to Assess Pharmacokinetics, Safety and Tolerability of PF-04965842 in Chinese Healthy Participants
NCT04099563
All Genders
18+
Years
Beijing,
Healthy Participants
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants
NCT04124653
All Genders
18+
Years
New Haven, Connecticut
Descriptive Information
Brief Title  ICMJE A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
Official Title  ICMJE Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioequivalence Study Comparing Sertraline Hydrochloride 50 mg Film-Coated Tablets To Sertraline Hydrochloride 50 mg Hard Capsules Under Fasted Conditions
Brief SummaryThis study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: sertraline hydrochloride
    50 mg capsule, single-dose
    Other Name: Zoloft
  • Drug: sertraline hydrochloride
    50 mg tablet, single-dose
    Other Name: Zoloft
Study Arms  ICMJE
  • Active Comparator: Sertraline 50 mg capsules
    Intervention: Drug: sertraline hydrochloride
  • Active Comparator: Sertraline 50 mg tablet
    Intervention: Drug: sertraline hydrochloride
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2010)		30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion DateDecember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01235195
Other Study ID Numbers  ICMJE A0501097
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now