Clinical Trials Logo
  1. Home
  2. Bacterial Infection
  3. NCT00939562
  4. Details
NCT00939562 Clinical Trial

Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00939562
Other study ID # A1901003
Secondary ID
Status Completed
Phase Phase 4
First received July 8, 2009
Last updated November 19, 2009
Start date November 2008
Est. completion date December 2008

Study information
Verified date November 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority India: University of Gujarat
Study type Interventional

Clinical Trial Summary

The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.

Recruitment information / eligibility
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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• doxycycline monohydrate tablet
Tablet, 100 mg, Single dose
• doxycycline carragenate tablet
Tablet, 100 mg, Single dose

Locations
Country Name City State
India Pfizer Investigational Site Ahmedabad Gujarat

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome
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
See also
  Status Clinical Trial Phase
Completed NCT02794831 - Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
Active, not recruiting NCT02533609 - Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
Completed NCT01892358 - Preventing Bacterial and Viral Infections Among Injection Drug Users N/A
Completed NCT01446289 - Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings Phase 2
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Completed NCT01059890 - Cerebral Antibiotics Distribution After Acute Brain Injury Phase 1
Completed NCT00389558 - Antiseptic Use and Dressing Application Phase 4
Completed NCT00760279 - An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates Phase 1
Completed NCT02311816 - Increase in Procalcitonin Kinetics May be a Good Indicator of Starting Empirical Antibiotic Treatment in Critically Ill Patients N/A
Completed NCT01225042 - The Effect of Probiotics on E. Coli Gastroenteritis N/A
Completed NCT00915213 - Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy N/A
Completed NCT00800488 - Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months N/A
Not yet recruiting NCT00765778 - Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community N/A
Terminated NCT00307099 - Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU Phase 3
Recruiting NCT04479657 - Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection Early Phase 1
Completed NCT03299894 - Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department N/A
Completed NCT01817075 - Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant Phase 3
Completed NCT01244698 - Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction Phase 4
Completed NCT01250574 - Neutrophil CD64 and Procalcitonin as Novel Biomarkers for Postoperative Infections
Completed NCT01012089 - Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease N/A

External Links