Back to resultsBioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Primary Purpose
Bacterial Infection
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
doxycycline monohydrate tablet
doxycycline carragenate tablet
Sponsored by
About this trial
This is an interventional basic science trial for Bacterial Infection focused on measuring Bioequivalence
Eligibility Criteria
Inclusion Criteria:
- Healthy male subjects between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 18 to 30 kg/m2.
Exclusion Criteria:
- Evidence or history of clinically significant abnormality.
- Any condition possibly affecting drug absorption.
- A positive urine drug screen.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
doxycycline monohydrate tablet
doxycycline carragenate tablet
Arm Description
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration (Cmax) of Doxycycline
Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline
AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00939562
Brief Title
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Official Title
An Open-Label, Two-Treatment, Two-Period, Randomized Cross-Over Study To Assess The Bioequivalence Between Commercial Doxycycline Carragenate And Monohydrate Tablet Formulations In Normal Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection
Keywords
Bioequivalence
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
doxycycline monohydrate tablet
Arm Type
Experimental
Arm Title
doxycycline carragenate tablet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
doxycycline monohydrate tablet
Intervention Description
Tablet, 100 mg, Single dose
Intervention Type
Drug
Intervention Name(s)
doxycycline carragenate tablet
Intervention Description
Tablet, 100 mg, Single dose
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) of Doxycycline
Time Frame
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
Title
Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline
Description
AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.
Time Frame
0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects between the ages of 18 and 55 years.
Body Mass Index (BMI) of 18 to 30 kg/m2.
Exclusion Criteria:
Evidence or history of clinically significant abnormality.
Any condition possibly affecting drug absorption.
A positive urine drug screen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 015
Country
India
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1901003&StudyName=Bioequivalence%20Between%20Two%20Tablet%20Formulations%20Of%20Doxycycline%20Carragenate
Description
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Learn more about this trial
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
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