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Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00532766
First Posted: September 20, 2007
Last Update Posted: September 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
King Saud University
  Purpose
To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.

Condition Intervention
Healthy Drug: Jusline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects

Further study details as provided by King Saud University:

Primary Outcome Measures:
  • To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)

Enrollment: 20
Study Start Date: November 2006
Study Completion Date: February 2007
Arms Assigned Interventions
Experimental: 2
Jusline Humulin
Drug: Jusline
Other Name: Humulin

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)).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532766


Locations
Saudi Arabia
University Diabetes Center
Riyadh, Saudi Arabia, 11461
Sponsors and Collaborators
King Saud University
Investigators
Principal Investigator: Khalid A Al-Rubeaan, MD College of Medicine, King Saud University
  More Information

ClinicalTrials.gov Identifier: NCT00532766     History of Changes
Other Study ID Numbers: CMRC06-535
First Submitted: September 19, 2007
First Posted: September 20, 2007
Last Update Posted: September 26, 2007
Last Verified: September 2007

Keywords provided by King Saud University:
Healthy subjects