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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

NCT04176367 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-01-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2020-09-29
Completion
2020-09-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04176367 on ClinicalTrials.gov