Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects
Information source: Wockhardt
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes
Intervention: Isophane insulin for inj. (Recomb Human insulin) (Wosulin N) (Biological); Isophane insulin for inj.(Recomb. Human Insulin) (Novolin N) (Biological)
Phase: Phase 1
Status: Recruiting
Sponsored by: Wockhardt Official(s) and/or principal investigator(s):
Heidi Guthrie, Study Chair, Affiliation: Profil Institute for Clinical Research
Overall contact:
Dr. Alexa Kollmeier, Phone: 619.409.1264, Email: alexa.kollmeier@profil-research.com
Summary
The aim of this trial is to demonstrate bioequivalence of Wosulin N to NovolinŽ N with
regard to its total and to its maximum serum insulin concentrations.
Clinical Details
Official title: A Randomized Single Center Double Blind 2 Period Crossover Glucose Clamp Study to Test for Bioequivalence Between 2 Recombinant Human Isophane Insulins Wockhardt's Human Isophane Insulin Injection100IU/ml With Novolin N in Healthy Subjects
Study design: Allocation: Randomized, Control: Active Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Primary outcome: Mean AUC0-24h and Cmax
Secondary outcome: PK endpts: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h,tmax,and elimination rate constant. PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,AUCGIR0-24h, AUCGIR6-12h, AUCGIR6-24h, GIRmax and tGIRmax Safety : AEs,haematology,biochem,phy exam.
Detailed description:
The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax
between Wosulin N and NovolinŽ N. The study also compares the pharmacokinetic and
pharmacodynamic profiles as well as assessing safety and local tolerability of the two
insulin preparations in healthy subjects.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male or female subject.
- Age more than 18 and less than 45 years.
- Considered generally healthy upon completion of medical history, physical
examination and biochemical investigations as judged by the Investigator.
- Body Mass Index (BMI) between 18. 0 and 27. 0 kg/m2, inclusive.
- Non-smoker, defined as no nicotine consumption for at least one year.
- Signed and dated informed consent obtained before any trial-related activities.
(Trial-related activities are any procedure that would not have been performed during
normal management of the subject.)
Exclusion Criteria:
- Previous participation in this trial or other clinical trials within the last 30
days.
- Pregnant, breast-feeding or intention of becoming pregnant or not using adequate
contraceptive measures (defined as intrauterine device (IUD) that has been in place
for at least 3 months, double barrier contraception, sterilization or abstinence, or
oral contraceptive pill, which should have been taken without difficulty for at least
3 months, or an approved hormonal implant).
- Clinically significant abnormal haematology or biochemistry screening tests, as
judged by the Investigator. In particular, subjects with elevated liver enzymes (AST
or ALT > 2 times the upper limit of normal) or impaired renal function (elevated
serum creatinine values above the upper limit of normal) will not be allowed to enter
the trial.
- Any serious systemic infectious disease during the four weeks prior to the first dose
of test drug, as judged by the Investigator.
- History of any illness that, in the opinion of the Investigator, might confound the
results of the trial or pose risk in administering the trial drug to the subject. In
particular, subjects with significant cardiovascular disease, anemia (haemoglobin
below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the
trial.
- History of alcohol or drug abuse in the past five years and/or any positive test for
drugs of abuse at screening.
- Any positive reaction of drugs of abuse.
- Hepatitis B or C or HIV positive.
- Use of prescription drugs within 3 weeks preceding the first dosing of insulin,
except for oral contraceptives/hormonal implants.
- Use of any insulin product for therapeutic purposes in the past.
- Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the
first dose of the test drug. Occasional use of acetaminophen is permitted.
- Mental incapacity, unwillingness or language barriers precluding adequate
understanding or co-operation.
- Blood donation of more than 500 ml within the last 12 weeks.
- History of multiple and/or severe allergies to drugs or foods or a history of severe
anaphylactic reaction.
- Known or suspected allergy to trial product or related products.
Locations and Contacts
Dr. Alexa Kollmeier, Phone: 619.409.1264, Email: alexa.kollmeier@profil-research.com
Profil Institute for clinical Research, Chula Vista, California 91911, United States; Recruiting
Dr. Alexa Kollmeier, Principal Investigator
Additional Information
Starting date: September 2008
Last updated: October 14, 2008
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