Status:
COMPLETED
A Study to Demonstrate Pharmacokinetic and Pharmacodynamic Biosimilarity Between HEC-Glargine and US-Lantus® in Healthy Male Volunteers
Lead Sponsor:
Lannett Company, Inc.
Collaborating Sponsors:
Parexel
FARMOVS (Pty) Ltd
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers.
Detailed Description
This will be a double-blind, single-dose, randomized, two-period, two-treatment, two-sequence crossover clamp study performed at a single study center. The study population consists of healthy adult m...
Eligibility Criteria
Inclusion
- Participant has body weight not less than 60 kg and body mass index between 18.5 and 30.0 kg/m\^2 (both inclusive).
- Glycohemoglobin (HbA1c) levels are \<6.0%.
- Normal oral glucose tolerance test conducted within the previous 6 months
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations should be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests
- Non-smokers or mild to moderate smokers (≤ 10 cigarettes or pipes per day).
Exclusion
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- Current alcohol use \>21 units of alcohol per week
- Regular exposure to substances of abuse (other than alcohol) within the past year.
- Use of any medication, prescribed or over-the-counter or herbal remedies
- Participation in another study with an experimental drug, where the last administration of the previous study drug was within 12 weeks before administration of study drug in this study.
- Treatment within the previous 3 months before the first administration of study drug with any drug with a well-defined potential for adversely affecting a major organ or system.
- A major disease (i.e., a disease that could not be treated at home, but the subject had to be hospitalized or needed general anesthesia usually for a major operation) during the 3 months before commencement of the screening period.
- Positive test for insulin antibodies.
- History of bronchial asthma or any other bronchospastic disease, and/or convulsions, and/or porphyria.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Resting pulse of \>100 beats per minute (bpm) or \<40 bpm during the screening period, either supine or standing.
- Hypertension diagnosed during screening or current diagnosis of hypertension.
- Hemoglobin count deviating more than 10% of the lower limit of normal.
- Clinically relevant abnormalities in the coagulation status.
- History of bleeding disorders.
- Veins unsuitable for venous blood collection and cannulation.
- Any specific study drug safety concern.
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT05248841
Start Date
March 8 2022
End Date
August 31 2022
Last Update
September 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
FARMOVS Clinical Research Organization
Bloemfontein, Free State, South Africa, 9301