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

NCT00939562 Phase 4 COMPLETED Results posted

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

Details

Lead sponsor	Pfizer
Phase	Phase 4
Status	COMPLETED
Enrolment	24
Start date	2008-11
Completion	2008-12

Conditions

• Bacterial Infection

Interventions

• doxycycline monohydrate tablet
• doxycycline carragenate tablet

Primary outcomes

• 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.
• 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.
  AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.

Countries

India