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

• ClinicalTrials.gov Identifier: NCT01235195
• Recruitment Status: Completed
• First Posted: November 5, 2010
• Results First Posted: May 7, 2012
• Last Update Posted: January 27, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: November 3, 2010
• First Posted Date: November 5, 2010
• Results First Submitted Date: November 21, 2011
• Results First Posted Date: May 7, 2012
• Last Update Posted Date: January 27, 2021
• Study Start Date: November 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2012)

• Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)] [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]
  AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).
• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]

Original Primary Outcome Measures (submitted: November 3, 2010)

• Area under the concentration time curve (AUC0-72) of sertraline hydrochloride 50 mg film-coated tablets and sertraline hydrochloride 50 mg hard gelatin capsules. [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]
• Peak plasma concentration (Cmax) of sertraline hydrochloride 50 mg film-coated tablets and sertraline hydrochloride 50 mg hard gelatin capsules. [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]

Current Secondary Outcome Measures (submitted: April 10, 2012)

• Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]
• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]
  AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
• Residual Area Under the Concentration Time Curve [AUC(Res%)] [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]
  AUC(res%) is the residual AUC defined as (AUCinf minus AUClast) divided by AUCinf. AUCinf is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUClast is the area under the plasma concentration-time curve from zero to the last measured concentration.
• Plasma Decay Half-Life (t1/2) [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose ]
  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Original Secondary Outcome Measures (submitted: November 3, 2010)

• Time at maximum concentration (Tmax) of sertraline hydrochloride [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours ]
• Area under the concentration time curve [AUC(0-∞)] of sertraline hydrochloride [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours ]
• Residual area under the concentration time curve [AUC(res%)] of sertraline hydrochloride [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours ]
• half-life (t1/2) of sertraline hydrochloride [ Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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 Summary: This 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• Drug: sertraline hydrochloride
  50 mg capsule, single-dose
  Other Name: Zoloft
• Drug: sertraline hydrochloride
  50 mg tablet, single-dose
  Other Name: Zoloft

Study Arms

• Active Comparator: Sertraline 50 mg capsules
  Intervention: Drug: sertraline hydrochloride
• Active Comparator: Sertraline 50 mg tablet
  Intervention: Drug: sertraline hydrochloride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 3, 2010): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT01235195
• Other Study ID Numbers: A0501097
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2021