← Back to Search

Insulin

I004 for Pharmacokinetics

Phase 2 & 3
Waitlist Available
Research Sponsored by Amphastar Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 60 minutes before dose until 12 hours after dose
Awards & highlights

Study Summary

This trial is testing whether a proposed biosimilar to NovoLog is equivalent in PK and PD.

Eligible Conditions
  • Pharmacodynamics
  • Pharmacokinetics

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body mass index (BMI) falls between 18.5 and 29.9 kg/m2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 60 minutes before dose until 2 hours after dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 60 minutes before dose until 2 hours after dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve (AUC) for Glucose Infusion Rate from time 0 to 12 hours post-dose, AUCG(0-12h)
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)
+3 more
Secondary outcome measures
Apparent Clearance of Insulin Aspart, CL/F
Apparent Volume of Distribution of Insulin Aspart, Vz/F
Area Under the Curve (AUC) for Glucose Infusion Rate (GIR) from time 0 to the Time of Last Measureable GIR, AUCG(0-last)
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Insulin Aspart, I004Experimental Treatment1 Intervention
Participants who were dosed with I004
Group II: NovoLogActive Control1 Intervention
Participants who were dosed with NovoLog
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
I004
2022
Completed Phase 3
~70

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project restrict participation to people under a certain age?

"The target age range for participants in this trial are individuals who are 65 years old or younger and have already reached the age of majority."

Answered by AI

Are patients who are taking other medications still able to enroll in this research project?

"This trial is seeking 60 patients that fit the pharmacokinetics age range of 18 to 65. Most notably, the patients must meet the following requirements: They must agree to participate and sign an informed consent form. They must be male or female, have a body mass index between 18.5 and 29.9 kg/m2, weigh at least 50 kg, have a fasting plasma glucose level below 100 mg/dL (5.5 mmol/L), have an HbA1c level below 5.7%, not have smoked for at least 3 months prior to screening, and if female, be post-menopausal, surg"

Answered by AI

How many people can potentially join this research project?

"That is correct. Currently, the clinicaltrials.gov website is listing this trial as actively recruiting patients. This study was posted on 8/22/2022 and was updated on 9/13/2022. They are looking for a total of 60 participants at 1 location."

Answered by AI
~27 spots leftby Mar 2025