Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

King Saud University20 enrolled

Overview

To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.

To study the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration in the abdominal, and to compare this profile with Humulin insulin for three different preparations (Regular, NPH, and Premixed Regular/NPH (30/70)).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

JuslineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy * Non-diabetic * Age 18-35 year * Normal body mass index (BMI 18-25 kg/m2) Exclusion Criteria: * Diabetics * Overweight/obese * Anemic, with liver, cardiac, renal or thyroid dysfunction

Locations (1)

University Diabetes Center

Riyadh, Riyadh Region, Saudi Arabia

Outcomes

Primary Outcomes

To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)

Data from ClinicalTrials.gov

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