Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

King Saud University

Status: Completed

Conditions: Healthy

Treatments: Drug: Jusline

Study type: Interventional

Funder types: Other

Identifiers

NCT00532766

CMRC06-535

Details and patient eligibility

About

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

Full description

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)).

Enrollment: 20 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 1 patient group

2

Experimental group

Description:

Jusline Humulin

Treatment:

Drug: Jusline