CTRI/2016/07/007096Not yet recruitingPhase 1
An assesor blind, balanced, randomized, two-treatment, two period, single-dose, two way crossover, comparative subcutaneous pharmacokinetic and pharmacodynamic study of two dose levels of INTP5 of Intas pharmaceuticals ltd., India Ahmedabad, India with two dose levels of Neulasta of Amgen (EU licensed product) in healthy, normal adult human subjects under fasting condition.
Intas Pharmaceuticals Ltd1 site in 1 country344 target enrollmentStarted: July 16, 2016Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Intas Pharmaceuticals Ltd
- Enrollment
- 344
- Locations
- 1
- Primary Endpoint
- Cmax, AUC0-t
Study Overview
Brief Summary
The objective of this study is to comparethe pharmacokinetic and pharmacodynamic effects and to assess bioequivalence oftwo dose levels of INTP5 of Intas Pharmaceuticals Ltd., India against two doselevels of Neulasta® of AMGEN (EU licensed Products) after singlesubcutaneous dose administration in adult, normal healthy subjects.
Through this study, we will prospectivelycollect the data on healthy subjects that are randomly assigned to receiveeither INTP5 of Intas Pharmaceuticals Ltd., India or Neulasta of AMGEN (EUlicensed Product-marketed by AMGEN Europe, BV) for the pharmacokinetic andpharmacodynamic profiling. No additional tests apart from already specified,will be performed. The study will therefore not put any additional risk/burdento the subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Non-smoking, healthy, normal, adult human volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- •Having a Body Mass Index (BMI) between 18.5 – 24.9 kg/m2 (both inclusive), and weight not <50 kg or > 100 kg.
- •Not having any significant disease in medical history or clinically significant abnormal findings during screening, abdominal ultrasonography, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
- •Ability to communicate effectively with study personnel.
- •5.Willingness to adhere to the protocol requirements.
- •Able to understand and give written informed consent for participation in the trial.
- •Both male and female patients of child bearing potential must be practicing adequate contraception.Female patients of child-bearing potential must not be orlikely to be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
Exclusion Criteria
- •Known hypersensitivity to the study drug or its constituents
- •Known case of hereditary fructose intolerance
- •Any clinically significant laboratory finding including ANC (Absolute Neutrophil Count), CD 34+, platelet or hemoglobin at the time of screening.
- •History or presence of other systemic disorders or diseases (e.g., haemopoietic, renal, hepatic, cardiovascular, respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement).
- •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 previous 6 months from the date of the screening visit.
- •History of any hematologic disease including sickle cell disorders
- •Receipt of over-the-counter medicines which have not yet cleared from the body (five half-lives must have passed for the medicine to be considered to have cleared from the body).
- •Smokers, or who have smoked within last six months prior to start of the study.
- •Consumption of tobacco or tobacco containing products within last six months prior to start of the study.
- •Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •The presence of clinically significant abnormal laboratory values during screening.
- •Positive result for human immunodeficiency virus (HIV I &/or II) and/or hepatitis B and C tests.
- •History or presence of psychiatric disorders.
- •Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug.
- •A history of difficulty in donating blood.
Outcomes
Primary Outcomes
Cmax, AUC0-t
Time Frame: Day 28
Secondary Outcomes
- Incidence of drug related Adverse Events as assessed by clinical examination, vitals and/or laboratory parameters for both the treatments(Day 28)
Investigators
Study Sites (1)
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