Recent Updates
Recently added Catalysts

Nicergoline from China

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Jan 27, 2021

Nicergoline from China development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Nicergoline from China clinical trials

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
Pharmacokinetics
NCT0417636740
Unlock 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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Explore more on BiopharmaWatch

Viatris Inc. (VTRS)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with NCompanies A to ZEvery biotech and pharma company we track