Status:
COMPLETED
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
Lead Sponsor:
Intas Pharmaceuticals, Ltd.
Collaborating Sponsors:
Lambda Therapeutic Research Ltd.
Conditions:
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) ...
Eligibility Criteria
Inclusion
- Normal, healthy adult human volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having body weight ≥50 kg and body mass index (BMI) between 18.5 and 29.9 (both inclusive), calculated as weight in kg/height in meter\^2.
- Not having any significant disease in medical history or clinically significant abnormal findings during screening, abdominal ultrasonography, medical history, clinical examination, laboratory evaluations, 12-lead ECG and chest X-ray (posterior-anterior view; within the last 6 months) recordings.
- Volunteer who is a Non-smoker
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
- In case of female subjects:
- Surgically sterilized at least 6 months prior to study participation;- Or - If a woman of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- Serum pregnancy test (for female subjects) must be negative.
Exclusion
- Known hypersensitivity to the study drug or its constituents and/or hypersensitivity to E. coli derived proteins, and/or previous exposure to the study drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Known case of hereditary fructose intolerance.
- Subjects with latex allergies will be excluded as the needle cover on the single-use pre-filled syringe contains dry natural rubber (latex).
- Any clinically significant laboratory finding including ANC, platelet, RBC count or hemoglobin level at the time of screening.
- Prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or Pegfilgrastim; Prior exposure to vaccines, immunoglobulin preparations, or immunomodulator's within the past 6 months prior to receiving the first dose; evidence of E. coli diarrhea or diseases within 3 months.
- Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs induced urticaria.
- Subjects with a history of pulmonary infiltrate or pneumonia in the last 6 months.
- History of any hematologic disease including sickle cell disorders.
- Smokers, or who have smoked within last six months prior to start of the study.
- Ingestion or use of any prescribed medication at any time within 1 month prior to receiving first dose in Period-I.
- Receipt of over-the-counter medicines which have not yet cleared from the body (5 half-lives must have passed for the medicine to be considered to have cleared from the body).
- A recent history of harmful use of alcohol, i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving study medicine in Period-I.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- Donation of blood (1 unit or 350 mL) or equivalent amount of blood substitute. Receipt of an investigational medicinal product or participation in a drug research study within a period of 180 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- Positive result for human immunodeficiency virus (HIV I \&/or II) and/or hepatitis B and C tests.
- History or presence of cancer because of which anticipated life span is less than 5 years as per the investigator's assessment.
- History or presence of psychiatric disorders.
- Presence of tattoo or scars or any type of skin lesions due to infection, burning, wound or inflammation at the proposed site of injection.
- An unusual diet, for whatever reason (e.g. low-sodium), for 4 weeks prior to receiving the study medicine in Period-I. In any such case, subject selection will be at the discretion of the Principal Investigator.
- Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug in Period-I.
- A history of difficulty in donating blood.
- Females, pregnant or lactating, or planning to become pregnant during the course of the study or found positive in pregnancy test at screening.
- Any infections in the last 4 weeks before receiving study medication in Period-I.
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04014062
Start Date
February 12 2018
End Date
May 1 2018
Last Update
October 4 2019
Active Locations (1)
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1
Lambda Therapeutic Research Ltd.
Ahmedabad, Gota, India, Ahmedabad-382481