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Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

This study has been completed.
Sponsor:
Information provided by:
King Saud University
ClinicalTrials.gov Identifier:
NCT00532766
First received: September 19, 2007
Last updated: September 24, 2007
Last verified: September 2007
History of Changes
  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: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

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 Names:
  • Jusline
  • 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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00532766     History of Changes
Other Study ID Numbers: CMRC06-535
Study First Received: September 19, 2007
Last Updated: September 24, 2007
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by King Saud University:
Healthy subjects

ClinicalTrials.gov processed this record on May 16, 2013