Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions

Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01570907
Collaborator
(none)
42
1
30
42.6

Study Details

Study Description

Brief Summary

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.

Condition or Disease Intervention/Treatment Phase
  • Drug: Quetiapine Fumarate
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fasting Conditions
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

  1. bioequivalence determined by statistical comparison Cmax [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
Exclusion Criteria:
  • Positive test for HIV, Hepatitis B, or Hepatitis C.

  • Treatment with known enzyme altering drugs.

  • History of allergic or adverse response to quetiapine or any comparable or similar product.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novum Pharmaceutical Research Services Houston Texas United States 77042

Sponsors and Collaborators

  • Roxane Laboratories

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01570907
Other Study ID Numbers:
  • QUET-T25-PVFS-2
First Posted:
Apr 4, 2012
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2018