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Sponsored by: |
King Saud University |
---|---|
Information provided by: | King Saud University |
ClinicalTrials.gov Identifier: | NCT00532766 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment |
Official Title: | Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects |
Enrollment: | 20 |
Study Start Date: | November 2006 |
Study Completion Date: | February 2007 |
Arms | Assigned Interventions |
---|---|
2: Experimental
Jusline Humulin
|
Drug: Jusline |
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)).
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Saudi Arabia | |
University Diabetes Center | |
Riyadh, Saudi Arabia, 11461 |
Principal Investigator: | Khalid A Al-Rubeaan, MD | College of Medicine, King Saud University |
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 |
Healthy subjects |
Healthy Insulin |