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CompletedNCT00602849Updated Jan 23, 2018

Bioequivalency Study of Sertraline Under Fasting Conditions

An interventional study of Sertraline in Depression, sponsored by Roxane Laboratories. Completed at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Roxane Laboratories (part of Hikma Pharmaceuticals) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

02

Conditions studied

  • Depression

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03

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 38 is below the median of 84 across 6,869 interventional studies indexed under Depression.

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Lead sponsor

Roxane Laboratories is the lead sponsor of 99 studies on the registry; none are open to participants now.

First submitted before Roxane Laboratories became part of Hikma Pharmaceuticals.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • Treatment with any triptan within 30 days prior to or during the study.
  • History of allergic or adverse response to sertraline or any comparable or similar product.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Bioequivalence

    Time frame: Baseline, Two period, Fourteen day washout

07

Study locations

1 site
  • Anapharm Inc.
    Sainte-Fly, Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00602849
First posted
Jan 28, 2008
Start date
Jun 2003
Primary completion
Jul 2003
Completion
Jul 2003
Last update
Jan 23, 2018

Study contacts

Benoit Girard, MD
principal investigator · Anapharm

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Sertraline

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