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

NCT00596063 | Completed Phase 1

• 2 other identifiers: Wosulin R/PK-PD/HV/FDA/07/v1Not yet created
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus

Keywords

pharmacokinetics; pharmacodynamics; recombinant human insulin; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  Visit 2 & 3

Secondary Outcomes (1)

• 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.

  Visit 2, 3 and 4

Study Arms (2)

Wosulin R

EXPERIMENTAL

Regular insulin for subcutaneous injection (recombinant human insulin), 600nmol, 100 IU

Biological: Wosulin R

Novolin R

ACTIVE COMPARATOR

Regular insulin for injection (recombinant human insulin)

Biological: Novolin R

Interventions

Wosulin R BIOLOGICAL

Penfill cartridges; Single Dose, 0.2 IU/ kg;

Wosulin R

Novolin R BIOLOGICAL

Penfill cartridges; Single Dose, 0.2 IU/ kg;

Novolin R

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (2)

Profil Institute for Clinical Research Inc.

Chula Vista, California, 91911, United States

Location

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Linda Morrow, M.D

  Profil Institute for Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

US (2)