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Nicergoline from China

Phase 1

Pharmacokinetics | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 27, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Nicergoline from China · 1 trial · 1 indication

Phase 1 1
NCT04176367An 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 ParticipantsPharmacokinetics
COMPLETED40 Analytics
PHASE1COMPLETED
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
PharmacokineticsUnlock trial analytics

Study Endpoints

Primary Endpoints

AUCinf of MDL (area under the plasma concentration-time profile derived from plasma from time 0 extrapolated to infinity)
At the end of Day 11

MDL is the primary metabolizer of Nicergoline

AUClast of MDL (area under the plasma concentration-time profile derived from plasma from time 0 to the last quantifiable concentration)
At the end of Day 11

MDL is the primary metabolizer of Nicergoline

Cmax of MDL (maximum observed concentration derived from plasma)
At the end of Day 11

MDL is the primary metabolizer of Nicergoline

Secondary Endpoints

AUCinf of MMDL (area under the plasma concentration-time profile derived from plasma from time 0 extrapolated to infinity)
At the end of Day 11
AUClast of MMDL (area under the plasma concentration-time profile derived from plasma from time 0 to the last quantifiable concentration)
At the end of Day 11
Cmax of MMDL (maximum observed concentration derived from plasma)
At the end of Day 11
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Test: Nicergoline manufactured in ChinaEXPERIMENTAL -
Reference: Nicergoline manufactured in ItalyACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Nicergoline from ChinaDRUGThis is the test arm of China local manufactured Nicergoline
Nicergoline from ItalyDRUGThis is the reference arm of Italy originator Nicergoline.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Age and Sex: 1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD). • Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. Type of...

Countries:China
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Frequently asked questions about Nicergoline from China

What is Nicergoline from China used for?

Nicergoline from China is a small molecule drug being studied for pharmacokinetics. It is currently in Phase 1 clinical development. The drug is being investigated in a bioequivalence study to compare a 10 mg tablet manufactured in China with a 10 mg tablet manufactured in Italy under fasted and fed conditions in healthy Chinese participants.

Who makes Nicergoline from China?

Nicergoline from China is being developed by Pfizer, Inc., which is listed on the stock exchange under the ticker PFE. The drug is currently in Phase 1 clinical development for pharmacokinetics.

What phase is Nicergoline from China in?

Nicergoline from China is in Phase 1 clinical development. It is an investigational drug being studied for pharmacokinetics. The drug has completed one Phase 1 trial, and it is not yet approved by regulatory authorities.

What clinical trials is Nicergoline from China in?

Nicergoline from China has one completed clinical trial, NCT04176367. This was a Phase 1 bioequivalence study comparing a 10 mg tablet manufactured in China with a 10 mg tablet manufactured in Italy under fasted and fed conditions in healthy Chinese participants. The trial enrolled 40 participants and was conducted in China.

Is Nicergoline from China the same as Nicergoline?

Nicergoline from China refers to a specific formulation of nicergoline, a small molecule drug, that is manufactured in China. It is being studied for pharmacokinetics and is currently in Phase 1 clinical development. The drug is being compared to a version manufactured in Italy in a bioequivalence study.