A Randomized, Double-Blind, Placebo-Controlled PhaseI Study To Determine The Safety, Tolerability,Pharmacokinetics And Pharmacodynamicsof Single and Multiple Ascending Doses Of PMZ-2010 {Drug for Hypovolemic shock} In Healthy Male Volunteers.
- Registration Number
- CTRI/2014/06/004647
- Lead Sponsor
- Pharmazz India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
•Age: 18-60 yr old, both inclusive
•Having a Body Mass Index (BMI) between 18.5-28
kg/m2 (both inclusive) and body weight not less than 45 kg
•Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; and to comply with the requirements of the entire study
•Voluntarily given written informed consent to participate in this study
•Be of normal health as determined by the principal investigator from medical history, physical examination and laboratory investigations, 12-lead ECG and X-ray chest of the subjects performed within 10 days prior to the admission of the study
•Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, coke, chocolate, power drinks) and grapefruit Guice) from 48 h prior to each admission until study completion
•Employees of FCRL or Pharmazz India Private Limited
•Not willing to use contraceptives (preferably condoms) during sexual activity for the period of 3 months from the date of check-in
•History of hypersensitivity and / or intolerance to Centhaquin or any other related compounds.
•History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
•Clinically abnormal ECG and Chest X-ray.
Physical findings: clinically relevant abnormal physical findings (including body temperature) suggesting underlying pathologies or those which could interfere with the objectives of the study.
•Laboratory values that are significantly different than the normal reference range and/or are deemed to be of clinical significance by the investigator
•Presence of reactive disease markers of HIV 1 and II, HBsAg, HCV or VDRL.
•Positive for alcohol breath test and/or urine drug screen (barbiturates, benzodiazepines, amphetamine, cocaine, opiates, tetra-hydro cannabinol).
•Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
•Diseases: relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, neurological or gastrointestinal diseases. History of depression, psychosis, schizophrenia or any other severe psychiatric diseases, or epilepsy, or any other illness that may interfere with the aim of the study. History of any significant illness in the 4 weeks preceding the screening
•Medications: history of intake of any medications including over the counter medications (OTC) and any herbal agents at least 4 weeks period prior to study drug administration.
•Investigational drug trials: participation in the evaluation of any drug in the 3 months prior to the start of the study (dosing with IMP).
•Blood donation: Subjects who, through completion of this study, would have donated and/or lost more than 300 mL of blood in the past 12 weeks
Note: In case the blood loss is <= 200 mL; subject may be dosed 60 days after blood donation or last sample of the previous study
•Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
•History of drug dependence or alcoholics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine safety and tolerability of PMZ-2010 after Single <br/ ><br>(SAD) and Multiple ascending close (MAD). <br/ ><br>Timepoint: Vitals : Cohort I to IV: At screening, admission, Pre-dose and 0.5, 1, 2, 4, 8, 12,24 and 48 h post-dose and on Day 5-7; For Cohort V to VI: At screening, admission, Pre-dose and 0.5, 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 52, 56, 60, 72 and 96 h post-dose and on Day 7-9. ECG Cohort I to IV: pre-dose and 1, 4, 8, 12, 24 h post-dose and at discharge. ECG Cohort V to VI: pre-dose and 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 52, 56, 60, 72 and 96 h post-dose.
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics (PK) of PMZ-2010 after Single <br/ ><br>and Multiple ascending dose. <br/ ><br>To determine exploratory Pharmacodynamic markers of PMZ-2010 in the study population <br/ ><br>Timepoint: Blood sampling for pharmacokinetic assessment for SAD: Pre-dose, 0.5, 1.0, 1.5, 2.0, 4.0, 8.0, 12.0 and 24.0 hrs after drug administration for analysis of the drug. Blood sampling for pharmacokinetic assessment for MAD: Pre-dose, 0.5, 1.0, 1.5, 2.0, 4.0, 7.0 hrs after first dose administration and predose will be collected in the subsequent dose and after the last dose at 0.5, 1.0, 1.5, 2.0, 4.0, 8.0, 12.0 and 24.0 hrs for analysis of the drug.