跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/CTRI/2010/091/001243
CTRI/2010/091/001243已完成未知

A Single Center, Open Label, Randomized, Two-Treatment, Two-Sequence, Single Period, Parallel, Single Dose, Pilot Study To Compare The Pharmacokinetics Of Marketed Product TobraDex® (Tobramycin And Dexamethasone Ophthalmic Suspension) To An Experimental Ophthalmic Sterile Suspension Containing Tobramycin 0.3% And Dexamethasone 0.1% W/V In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery.

Zumanta Pharmaceuticals0 个研究点目标入组 24 人开始时间: 待定最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
未知
状态
已完成
发起方
入组人数
24
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Ba/be

入排标准

入选标准

  • •Inclusion Criteria
  • •a.Be male or female 18 to 55 years of age, both ages inclusive.
  • •b.Presence of cataract in both the eyes and indicated for extracapsular cataract extraction.
  • •c.Patients with LCOS III classification.
  • •d.Be in the weight range as per Life Insurance Corporation of India, Underwriting Charts & Summary of Rules (As on 30-1-93), II UNDERWEIGHT AND OVERWEIGHT MIN & MAX CHART. (Refer Appendix- 4). Patients weighing less than 50 kg will not be enrolled.
  • •e.Be able to communicate effectively with the study personnel.
  • •f.Be a non consumer (user) of tobacco (not consumed tobacco in the past 6 months) or a mild or moderate consumer (user) of tobacco.
  • •g.Have no evidence of underlying active disease during screening medical history and whose physical examination is performed within 21 days prior to check in.
  • •h.Be medically fit with clinically acceptable laboratory profiles, ECG (performed within 21 days prior to check-in) and chest X-ray (performed within 6 months prior to check-in).
  • •i.Have given the written informed consent for participation in the study.
  • •j.Be declared eligible to participate in the study by the investigator (s).
  • •k. In addition, female patients selected for the study must:
  • •i)Be using a medically acceptable form of birth control (such as foams, jellies, diaphragm, intra-uterine device (IUD) or abstinence) for the duration of the study as judged by the investigator(s) Or
  • •ii)Be sterilized by surgical methods (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) at least 6 months back
  • •iii)Have attained menopause at least 1 year back.
  • •iv)And have a negative urine pregnancy test prior to check-in to the clinical facility

排除标准

  • •Exclusion Criteria
  • •Any of the following conditions are cause for exclusion from the study:
  • •a.Participation in any bioavailability/bioequivalence/Pharmacokinetic study or received an investigational drug within a period of 3 months prior to check in.
  • •b.Presence or history of epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella of the cornea and conjunctiva.
  • •c.History of ?recent (last 15 days)? or ?active? viral diseases of the cornea and conjunctiva.
  • •d.Presence or history of uveitis or uveitis within the previous 12 months, or laser-assisted in-situ keratomileusis, photorefractive, keratectomy, radial keratotomy, or similar surgery in the previous 3 months.
  • •e.Ocular trauma within 3 months of the trial, active external ocular disease, inflammation, or infection (mycobacterial or fungal disease) of the study eye and corneal diseases or disruption.
  • •f.Patients who had received dexamethasone or beclamethasone within 7 days of check in.
  • •g.Presence of uncontrolled diabetes.
  • •h.History of drug abuse, or alcohol dependence or abuse.
  • •i.History of any allergies (asthma, urticaria) including drug allergies.
  • •j.Known hypersensitivity or allergy to TobraDex® in combination or its components.
  • •k.Severe consumer (user) of tobacco.
  • •l.Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, or nervous system(s) or psychiatric disease or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the patient at increased risk, as determined by the investigator(s).
  • •m.Patients who have:
  • •i.Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician /investigator (s).
  • •ii.Pulse rate below 60 per minute or above 100 per minute.
  • •iii.Respiratory rate below 15 or above 20 breaths per minute.
  • •iv.Oral temperature less than 96.2oF or more than 99.8oF.
  • •n.Clinical laboratory test values outside the acceptable reference range and when confirmed on re-examination deemed to be clinically significant.
  • •o. Positive screening results for Hepatitis B, Hepatitis C, HIV or Syphilis.
  • •p.Clinically significant illness during the 4 weeks prior to check-in (as determined by the investigators).
  • •q.Change in existing prescription drug(s) for systemic action in the 14 days prior to check-in or OTC drug in the 14 days since last visit.
  • •r.Positive result in breath analysis test for alcohol.
  • •s.Positive urine drug screening results for any of the following: cocaine, THC, barbiturates, amphetamines, benzodiazepines, and morphine.
  • •t.Positive test for pregnancy for female patients

研究者

发起方
Zumanta Pharmaceuticals

相似试验

招募中
不适用
Clinical bioequivalence study of Nevirapine Prolonged Release Tablets 400 mg in HIV-1 infected patients
CTRI/2018/01/011185APL Research Center
已完成
1 期
A study to find out the variation in the absorption of SPA100 (aliskiren/amlodipine 300/10 mg oral tablets) when given with and with out food
CTRI/2009/091/000762ovartis Healthcare Private Limited,Andhra Pradesh, India 500 081.36
已完成
不适用
A single-center, two-part, randomized, open-label, parallel-group, four-sequence, four-treatment, four-period crossover study to investigate the bioequivalence and the effect of food on the pharmacokinetics and safety of single oral doses of two different formulations of RO6868847 in healthy participants
NL-OMON51381Hoffmann-La Roche48
尚未招募
不适用
A bioequivalance study comparing Tobradex eye drops of Alcon pharma with study medication with same combination of Cipla in aqueous humor of patients undergoing cataract surgery.
CTRI/2015/10/006326Cipla Ltd36
已完成
3 期
(Pivotal study)PK of TobraDex is compared with Tobramycin 0.3% And Dexamethasone 0.1%(Study drug) W/V In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery.
CTRI/2010/091/003008Zumanta Pharmaceuticals LLC552