Phase 4
N=24
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
Bacterial Infection
Bottom Line
View on ClinicalTrials.gov: NCT00939562 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Maximum Plasma Concentration (Cmax) of Doxycycline — 2.526; 2.442 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- doxycycline monohydrate tablet (Drug); doxycycline carragenate tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of Doxycycline |
2.526; 2.442 | — |
| PRIMARY Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline |
56.297; 54.026 | — |
Summary
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
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.
Data sourced from ClinicalTrials.gov (NCT00939562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.