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

Recruiting Phase 2 Phase 3 Interventional Study
Pharmacokinetics Pharmacodynamics Insulin Aspart
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Amphastar Pharmaceuticals, Inc. · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
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 repe…
Contacts

Amphastar Pharmaceuticals, Inc.

909-980-9484

info@amphastar.com

CONTACT