Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.

Completed · Phase 1

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp.

Key facts

Study ID

NCT00596063

Run by

Wockhardt

People needed

25

Starts

2008-01-01

Expected to finish

2008-02-01

Last updated by the study team

2012-12-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female subject.
• Age ≥ 18 and ≤ 45 years.
• 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.).

You may not qualify if…

• Previous participation in this trial or other clinical trials within the last 3 months.
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant).
• Clinically significant abnormal hematology 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.
• 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 paracetamol 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.

Where it is running

• Profil Institute for Clinical Research Inc. — Chula Vista, California, United States
• Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.