Evaluating Pharmacokinetics and Pharmacodynamics of Jusline | NCT00532766

Studies
Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

NCT00532766

Sponsor

King Saud University

Status

Completed

Last Update Posted

Sep 26, 2007Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Jusline

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Sep 19, 2007

First Submission Date that Met QC Criteria

Sep 19, 2007

First Posted Date

Sep 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2007

Last Update Posted Date

Sep 26, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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)).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
2	Experimental	Jusline Humulin	Drug: Jusline

Name	Type	Description	Arm Group Labels	Other Names
Jusline	Drug		2	Humulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Khalid A Al-Rubeaan, MD	College of Medicine, King Saud University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Diabetes Center		Riyadh	Riyadh Region	11461	Saudi Arabia

Intervention Browse Module

MeSH Terms

ID	Term
D061386	Insulin, Regular, Human

Ancestor Terms

ID	Term
D007328	Insulin
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361

Browse Leaves

Not provided

Browse Branches

Not provided