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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

August 22, 2022

Primary Completion Date

January 29, 2023

Study Completion Date

January 30, 2023

Conditions
PharmacokineticsPharmacodynamics
Interventions
DRUG

I004

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 Treatment Period 1 under fasting condition.

DRUG

NovoLog

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 Treatment Period 1 under fasting condition.

Trial Locations (1)

91911

Amphastar Study Site, Chula Vista

All Listed Sponsors
lead

Amphastar Pharmaceuticals, Inc.

INDUSTRY

NCT05539872 - 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 | Biotech Hunter | Biotech Hunter