NCT00834912

Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of two Tramadol Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites, administered as 1 x 300 mg controlled-release tablet under fasting conditions. The effect of food on the to-be-marketed formulation was also assessed.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tramadol hydrochloride	1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.
DRUG	Tramadol HCl	1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.
DRUG	Tramadol HCl	1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall.

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2009-02-03
• Last updated: 2012-04-30
• Results posted: 2009-10-19