A randomized, single-site, open-label, 2-way crossover, single-dose Phase I clinical trial to assess the bioequivalence of 2 tablets of a tapentadol 25 mg prolonged-release tablet formulation and 1 tablet of a tapentadol 50 mg prolonged-release tablet formulation in healthy male subjects under fed conditions

Completed

• Conditions: chronische pijn bij volwassenen; chronic pain in adults

• Registration Number: NL-OMON46632
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-Healthy male subjects
-18-55 yrs, inclusive
-BMI: 20.0-28.0 kg/m2, inclusive, with a body weight of no less than 50 kg.
-non-smoking or light-smoking

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 30 days from the start of the study. In case of donating more than 500 ml of blood in the 3 months prior the start of this study.;Evidence or history of alcohol or drug abuse including positive or missing alcohol urine test or
drugs of abuse test.

Study & Design

• Study Type: Interventional
• Study Design: Not specified