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: Triple (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

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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 September 21, 2017

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