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: A Single-Center Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence, Crossover, Hyperinsulinemia-Euglycemic Clamp Study
Amphastar Pharmaceuticals, Inc.
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 pharmacodynamic (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Upon review, agree to participate and sign informed consent. * Healthy male and female subjects ≥ 18 to ≤ 65 years of age. * Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2 * Weight ≥ 50 kg. * Fasting plasma glucose of \< 100 mg/dL (5.5 mmol/L) measured with YSI at site; one repeat test is allowed. * HbA1c \< 5.7%. * Non-smoker for ≥ 3 months prior to Screening. * Female candidates must be \> 1 year post-menopausal, surgically sterile, or practicing a clinically acceptable form of birth control and confirmed by negative serum pregnancy test at Screening. Exclusion Criteria…
Interventions
- DrugI004
Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition.
- DrugNovoLog
Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Day -1 of Treatment Period 1 under fasting condition.
Location
- Amphastar Study SiteChula Vista, California