Clinical trial NCT00596063: Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.
Official title: A Randomized, Single Center, Double Blind, Two Period, Crossover Glucose Clamp Study to Test for Bioequivalence Between Two Recombinant Human Soluble Insulins- Wockhardts Insulin Human Regular for Injection and Novolin R in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: pharmacokinetics
pharmacodynamics
recombinant human insulin
healthy volunteers
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers. It is a crossover study. The subjects shall be administered single doses of each insulin during two separate visits under the conditions of euglycemic clamp.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subject.
2. Age ≥ 18 and ≤ 45 years.
3. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
4. Non-smoker, defined as no nicotine consumption for at least one year.
5. 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:

1. Previous participation in this trial or other clinical trials within the last 3 months.
2. 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).
3. 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.
4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
5. 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.
6. History of alcohol or drug abuse.
7. Any positive reaction of drugs of abuse.
8. Hepatitis B or C or HIV positive.
9. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
10. Use of any insulin product for therapeutic purposes in the past.
11. 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.
12. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
13. Blood donation of more than 500 ml within the last 12 weeks.
14. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
15. Known or suspected allergy to trial product or related products.

Primary outcomes:
measure: The primary objective is to test for bioequivalence based on AUC0-12h and Cmax between Wockhardt's Insulin Human Regular for injection and Novolin® R
timeFrame: Visit 2 & 3
Secondary outcomes:
measure: PK endpoints: AUC, tmax and t½ PD endpoints: AUC-GIR, GIRmax and tGIRmax Safety endpoints: AEs, haematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability.
timeFrame: Visit 2, 3 and 4
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research Inc.
state: California
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research, Inc.
state: California
Study officials:
affiliation: Profil Institute for Clinical Research, Inc.
name: Linda Morrow, M.D
role: PRINCIPAL_INVESTIGATOR
References: