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Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

Not Applicable
Completed
Conditions
Healthy
Interventions
Drug: Jusline
Registration Number
NCT00532766
Lead Sponsor
King Saud University
Brief Summary

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

Detailed 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)).

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
2JuslineJusline Humulin
Primary Outcome Measures
NameTimeMethod
To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Diabetes Center

🇸🇦

Riyadh, Saudi Arabia

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