Status and phase
Conditions
Treatments
About
The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. Following an overnight fast of at least 10 hours, subjects consumed a standard high-calorie. high-fat breakfast meal. This standard breakfast meal began 30 minutes prior to each dose.
Full description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
All subjects must satisfy the following criteria to be considered for study participation:
Exclusion Criteria
Subjects may be excluded for any of the following:
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal