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Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

NCT ID: NCT00532766

Last Updated: 2007-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-02-28

Brief Summary

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To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.

Detailed Description

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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)).

Conditions

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Healthy

Keywords

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Healthy subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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2

Jusline Humulin

Group Type EXPERIMENTAL

Jusline

Intervention Type DRUG

Interventions

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Jusline

Intervention Type DRUG

Other Intervention Names

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Humulin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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King Saud University

OTHER

Sponsor Role lead

Principal Investigators

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Khalid A Al-Rubeaan, MD

Role: PRINCIPAL_INVESTIGATOR

College of Medicine, King Saud University

Locations

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University Diabetes Center

Riyadh, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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CMRC06-535

Identifier Type: -

Identifier Source: org_study_id