Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers
NCT00745186 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2017-03-20
Summary
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.
Conditions
Interventions
- DRUG
-
Glucagen
0.2 mg or 1 mg Glucagen single injection
- DRUG
-
Mayne Glucagon
0.2 mg or 1 mg Mayne Glucagon
Sponsors & Collaborators
-
Hospira, now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Stuart Mair · Syneos Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-08-31
- Primary Completion
- 2007-10-31
- Completion
- 2008-03-31
Countries
- United Kingdom
Study Locations
More Related Trials
-
A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes
NCT01849289 ·Status: COMPLETED ·Phase: PHASE3
-
Single Ascending Doses of ZP4207 Administered in HV and in T1D to Evaluate Safety, Tolerability PKs and PDs of ZP4207 Compared to a Comparator
NCT02367053 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
NCT02739906 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
NCT02034513 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
NCT00184613 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine
NCT00976391 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus
NCT03166124 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
NCT03286751 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
NCT02058160 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
NCT02910518 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Demonstrate Pharmacokinetic and Pharmacodynamic Biosimilarity Between HEC-Glargine and US-Lantus® in Healthy Male Volunteers
NCT05248841 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
NCT01676220 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
NCT00653341 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
NCT04276207 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Apidra to Regular Insulin in Hospitalized Patients
NCT00528918 ·Status: COMPLETED ·Phase: NA
-
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
NCT01455142 ·Status: COMPLETED ·Phase: PHASE1
-
Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition
NCT01081938 ·Status: TERMINATED ·Phase: PHASE4
-
Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers
NCT00969592 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402)
NCT01278485 ·Status: COMPLETED
-
Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus
NCT01364428 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
NCT01868529 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus
NCT00290979 ·Status: COMPLETED ·Phase: PHASE3
-
Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
NCT02133118 ·Status: COMPLETED
-
Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30
NCT04022291 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of LY3192767 in Healthy Participants
NCT03025009 ·Status: COMPLETED ·Phase: PHASE1