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Nicergoline from China

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 ParticipantsPHASE1 COMPLETED 40 — — Dec 17, 2019Sep 29, 2020Jan 27, 20211 China
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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 — 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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