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 (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


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

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

Keywords provided by King Saud University:


Healthy subjects

ClinicalTrials.gov processed this record on June 23, 2017

To Top