Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
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
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 8, 2009
CompletedFirst Posted
Study publicly available on registry
July 15, 2009
CompletedResults Posted
Study results publicly available
December 23, 2009
CompletedDecember 23, 2009
November 1, 2009
1 month
July 8, 2009
November 19, 2009
November 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum Plasma Concentration (Cmax) of Doxycycline
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.
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.
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.
Study Arms (2)
doxycycline monohydrate tablet
EXPERIMENTALdoxycycline carragenate tablet
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects between the ages of 18 and 55 years.
- Body Mass Index (BMI) of 18 to 30 kg/m2.
You may not qualify if:
- Evidence or history of clinically significant abnormality.
- Any condition possibly affecting drug absorption.
- A positive urine drug screen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 015, India
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 8, 2009
First Posted
July 15, 2009
Study Start
November 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
December 23, 2009
Results First Posted
December 23, 2009
Record last verified: 2009-11