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OpenTrials
Completed

NCT Number: NCT00532766

Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

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

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Diabetes Center

Riyadh, Riyadh Region, 11461, Saudi Arabia

About this study

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)).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jusline

Drug

Other names: Humulin

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects

Important dates

Study start
2006
Study completion
2007
First posted
Sep 20, 2007
Registry last updated
Sep 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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