NCT04176367

An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactured in Italy Under Fasted and Fed Conditions in Healthy Chinese Participants

AN OPEN LABEL, RANDOMIZED, SINGLE DOSE, 2 WAY CROSSOVER BIOEQUIVALENCE STUDY COMPARING NICERGOLINE 10 MG TABLET (MANUFACTURED AT PFIZER DALIAN, CHINA) WITH NICERGOLINE 10 MG TABLET (MANUFACTURED AT PFIZER ITALIA S.R.L., ITALY) UNDER FASTED AND FED CONDITIONS IN HEALTHY CHINESE PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial is a bioequivalence study to support a generic consistency evaluation program, initiated by the China Food and Drug Administration (CFDA) in 2015, for the evaluation of quality and efficacy of the products manufactured in China. Related guidance was issued by Center for Drug Evaluation (CDE) on 27 Nov 2015 named "Use pharmacokinetic (PK) parameter as endpoint for chemical generics bioequivalence (BE) study". Nicergoline localized product is manufactured at Pfizer Dalian China, while the reference product is manufactured at Pfizer Italia S.r.l., Italy. The selected strength of 10 mg tablet is the marketed strength in China, and the selected dose of 30 mg (3 x 10 mg tablet) is one of the commonly used clinically approved daily doses with good tolerability profile. In each group, participants will be randomized to one of the 2 treatment sequences according to a computer generated randomization schedule. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between the first day of each period.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Nicergoline from China	This is the test arm of China local manufactured Nicergoline
DRUG	Nicergoline from Italy	This is the reference arm of Italy originator Nicergoline.

Timeline

• Start date: 2019-12-17
• Primary completion: 2020-09-29
• Completion: 2020-09-29
• First posted: 2019-11-25
• Last updated: 2021-01-27

Locations

1 site across 1 country: China