Actively Recruiting
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers
Led by Amphastar Pharmaceuticals, Inc. · Updated on 2026-04-30
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
CONDITIONS
Official Title
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to participate and sign informed consent
- Healthy males and females aged 18 to 65 years
- Body mass index (BMI) between 18.5 and 29.9 kg/m2
- Weight of at least 50 kg
- Fasting plasma glucose less than 100 mg/dL measured at site, with one repeat test allowed
- HbA1c less than 5.7%
- Non-smoker for at least 3 months before screening
- Female participants must be more than 1 year post-menopausal, surgically sterile, or practicing an accepted form of birth control with a negative serum pregnancy test at screening
You will not qualify if you...
- History of diabetes mellitus
- Resting blood pressure higher than 140/90 mmHg or lower than 90/60 mmHg (may be re-checked)
- Participation in another investigational drug or device study within 30 days or 5 half-lives of the last dose
- History of serious adverse reaction or allergy to study drug components
- Significant history or current cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, neurological, or other major systemic diseases
- Evidence of active neuropsychiatric disease or use of related prescription medications
- Clinically significant abnormal physical, lab, or ECG findings at screening
- Long QT syndrome, family history of it, or corrected QT interval above 450 ms in men or 470 ms in women
- Elevated liver enzymes (AST or ALT) greater than 2.5 times normal
- History of fainting (syncope)
- Major surgery within 6 months
- Active infections other than mild viral illness within 30 days prior to dosing
- History or family history of blood clots
- Positive test or history of hepatitis B, hepatitis C, or HIV
- Use of systemic glucocorticoids within 3 months before screening
- History of alcohol abuse or high alcohol intake, or positive alcohol test at screening
- History or evidence of illicit drug use or positive drug test at screening
- Blood donation or loss of more than 500 mL within 56 days
- Chronic use of medications within 7 or 14 days before dosing except certain supplements or birth control
- Inability to comply with safety monitoring or considered unsuitable by investigator
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amphastar Study Site
Chula Vista, California, United States, 91911
Actively Recruiting
Research Team
A
Amphastar Pharmaceuticals, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here