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Mayne Glucagon

Phase 1

Hypoglycemia | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Mar 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Mayne Glucagon · 1 trial · 1 indication

Phase 1 1
NCT00745186Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy VolunteersHypoglycemia
COMPLETED28 Analytics
PHASE1COMPLETED
Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers
Hypoglycemia
NCT0074518628
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Study Endpoints

Primary Endpoints

Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Glucagon Concentration Observed (Cmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Blood Glucose Concentration Observed (BG Cmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25,30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.

Secondary Endpoints

Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Time at which Cmax occurs (Tmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Elimination half life (T1/2) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORGlucagen
2EXPERIMENTALMayne Glucagon

Interventions

NameTypeDescription
GlucagenDRUG0.2 mg or 1 mg Glucagen single injection
Mayne GlucagonDRUG0.2 mg or 1 mg Mayne Glucagon
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Male or female aged 18-50 years inclusive * Body weight between 50 - 100 kg and body mass index (BMI) between 18 and 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator * Non-smokers or ex-smokers who have not smoked with in the...

Countries:United Kingdom
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