NCT04229602

Bioequivalence Study of Venlafaxine Hydrochloride Sustained-Release Capsules in Chinese Healthy Volunteers

Bioequivalence Study of Venlafaxine Hydrochloride Sustained-Release Capsules and EFEXOR® XR Under Fed Conditions in Chinese Healthy Volunteers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the human bioequivalence of two Venlafaxine Hydrochloride Sustained-Release Capsules (75 mg) .

Detailed description

The objective of this study is to evaluate the human bioequivalence of Venlafaxine Hydrochloride Sustained-Release Capsules (75 mg) produced by Beijing Winsunny Pharmaceutical Co., Ltd and EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD), as well as the safety of the tested preparation, and to provide basis for the evaluation of the quality and efficacy consistency of the tested preparation and the reference preparation.

Conditions

• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg	A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
DRUG	EFEXOR® XR	EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD)

Timeline

• Start date: 2020-01-02
• Primary completion: 2020-04-02
• Completion: 2020-07-02
• First posted: 2020-01-18
• Last updated: 2020-01-18

Locations

1 site across 1 country: China