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Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

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ClinicalTrials.gov Identifier: NCT00532766
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : September 26, 2007
Sponsor:
Information provided by:
King Saud University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Jusline Not Applicable

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)).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : November 2006
Actual Study Completion Date : February 2007
Arms and Interventions
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Arm Intervention/treatment
Experimental: 2
Jusline Humulin
 Drug: Jusline
Other Name: Humulin


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

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Keywords provided by King Saud University:
Healthy subjects