Conditions: Healthy Subjects Pharmacokinetics Bioavailability
Keywords: Healthy subjects Pharmacokinetics Bioavailability
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: yes

Brief summary:
The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure) after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference product) and 200 mg 24-hourly at 07:30 (test product), were compared.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Tramadol HCl intervention 2: Tramadol HCl
Intervention descriptions: intervention 1: 1x200 mg Tramadol HCl OAD tablet daily intervention 2: 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly

Protocol document: