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Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers

NCT05539872•Amphastar Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

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

•History of diabetes mellitus.
•Resting blood pressure (BP) \> 140/90 mmHg or \< 90/60 mmHg. Subjects BP may be re-checked.
•Participation in an investigational drug/device study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.
•History of any serious adverse reaction or hypersensitivity to any of the investigational product components.
•Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the investigator, would unduly risk the subject's safety or may impact the conduct of the study.
•Subject shows evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant/anti-anxiety medication).
•Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject (laboratory results may be re-checked once on a separate day per Investigator discretion).
•Long QT syndrome or family history of long QT syndrome or corrected QT interval (QTcF) \> 450 ms in men, \> 470 ms in women at Screening.
•Liver function test results of AST and/or ALT ≥ 2.5 upper normal limit (ULN)
•Subject has a history of syncope.
+9 more criteria

Locations (1)

Amphastar Study Site

Chula Vista, California, United States

Key Dates

Start Date

August 22, 2022

Primary Completion Date

January 29, 2023

Completion Date

January 30, 2023

Last Updated

March 5, 2026

Enrollment

ACTUAL participants

Conditions

PharmacokineticsPharmacodynamics

Interventions

I004

DRUG

NovoLog

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Investigating the Pharmacokinetics of Tafenoquine in Healthy Papua New Guinean Children

PK/PD of Caspofungin in Children Severe Infection

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

Antibiotic Dosing in Pediatric Intensive Care

Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants