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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00532766 |
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Date of registration:
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19/09/2007 |
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Primary sponsor: |
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Public title:
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Evaluating Pharmacokinetics and Pharmacodynamics of Jusline
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Scientific title:
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Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00532766 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Khalid A Al-Rubeaan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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College of Medicine, King Saud University |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Jusline
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Primary Outcome(s)
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To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)
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Secondary ID(s)
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CMRC06-535
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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