At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Doxycycline Monohydrate +1 moredrug
Likely dose
Doxycycline Monohydrate 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study of Doxycycline Monohydrate 25 mg as a 5 mL Oral Suspension Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Doxycycline Monohydrate for Healthy. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
Primary CompletionOct 2006
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartOct 1, 2006
Primary CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Doxycycline Monohydratedrug
25 mg 5 mL dose
Doxycycline Monohydratedrug
25 mg 5 mL dose