Evaluating Pharmacokinetics and Pharmacodynamics of Jusline - Full Text View

Sponsored by:	King Saud University
Information provided by:	King Saud University
ClinicalTrials.gov Identifier:	NCT00532766

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

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment
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
2: Experimental Jusline Humulin	Drug: Jusline

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

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

Keywords provided by King Saud University:

Healthy subjects

Study placed in the following topic categories:

Healthy
Insulin

ClinicalTrials.gov processed this record on January 16, 2009