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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

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
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 26, 2016