Bacterial Infection Clinical Trial
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
Verified date | November 2009 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: University of Gujarat |
Study type | Interventional |
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
India | Pfizer Investigational Site | Ahmedabad | Gujarat |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Primary | Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) 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. | No |
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