I004 for Pharmacokinetics

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Amphastar Study Site, Chula Vista, CA
Pharmacokinetics+1 More
I004 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.

Eligible Conditions

  • Pharmacokinetics
  • Pharmacodynamics

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pharmacokinetics

Study Objectives

6 Primary · 17 Secondary · Reporting Duration: From 60 minutes before dose until 12 hours after dose

Hour 12
Apparent Clearance of Insulin Aspart, CL/F
Apparent Volume of Distribution of Insulin Aspart, Vz/F
Area Under the Curve (AUC) of Human Insulin Serum Concentration from time 0 to 12 hours post-dose, AUCHI(0-12h)
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration from time 0 to 12 hours post-dose, AUCIA(0-12h)
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration from time 0 to infinity, AUCIA(0-∞)
Half-life of Insulin Aspart, t1/2
Maximum Serum Human Insulin Concentration, CHImax
Maximum Serum Insulin Aspart Concentration, CIAmax
Time of Maximum Human Insulin Serum Concentration, tHImax
Time of Maximum Insulin Aspart Serum Concentration, tIAmax
Hour 2
Area Under the Curve (AUC) of Insulin Aspart Serum Concentration from time 0 to 2 hours post-dose, AUCIA(0-2h)
Hour 12
Area Under the Curve (AUC) for Glucose Infusion Rate (GIR) from time 0 to the Time of Last Measureable GIR, AUCG(0-last)
Area Under the Curve (AUC) for Glucose Infusion Rate due to Insulin Aspart from time 0 to 12 hours post-dose, AUCGA(0-12h)
Area Under the Curve (AUC) for Glucose Infusion Rate from time 0 to 12 hours post-dose, AUCG(0-12h)
Last Measureable Glucose Infusion Rate, Glast
Maximum Glucose Infusion Rate due to Insulin Aspart, GAmax
Maximum Glucose Infusion Rate, Gmax
Time of Glucose Infusion Start, tGonset
Time of Last Measureable Glucose Infusion Rate, tGlast
Time of Maximum Glucose Infusion Rate, tGmax
Time to Half of Maximum Glucose Infusion Rate (Gmax) After Gmax Is Reached, tG50%late
Time to Half of Maximum Glucose Infusion Rate (Gmax) Before Gmax Is Reached, tG50%early
Hour 2
Area Under the Curve (AUC) for Glucose Infusion Rate from time 0 to 2 hours post-dose, AUCG(0-2h)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Pharmacokinetics

Trial Design

2 Treatment Groups

NovoLog
1 of 2
Insulin Aspart, I004
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: I004 · No Placebo Group · Phase 2 & 3

Insulin Aspart, I004
Drug
Experimental Group · 1 Intervention: I004 · Intervention Types: Drug
NovoLog
Drug
ActiveComparator Group · 1 Intervention: NovoLog · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from 60 minutes before dose until 12 hours after dose
Closest Location: Amphastar Study Site · Chula Vista, CA
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N/AFirst Recorded Clinical Trial
1 TrialsResearching Pharmacokinetics
0 CompletedClinical Trials

Who is running the clinical trial?

Amphastar Pharmaceuticals, Inc.Lead Sponsor
19 Previous Clinical Trials
1,553 Total Patients Enrolled
1 Trials studying Pharmacokinetics
28 Patients Enrolled for Pharmacokinetics

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a non-smoker for at least 3 months prior to Screening.
You are female and you are not pregnant or you are not surgically sterile.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.