CTRI/2024/02/062668尚未招募Unknown
Quality Control Testing and Bio-Equivalence Study of Amoxicillin-Clavulanic Acid Generic Tablets Procured by A Tertiary Care Centre in India - NI
Post Graduate Institute of Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Signed and dated informed consent document indicating that they have been informed of all pertinent aspects of the study before any assessment is done
- •2 A participant who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions and other study procedures
- •3 A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, as determined by medical evaluation, including medical history, full physical examination, including blood pressure and pulse rate measurement, ECG or clinical laboratory tests
- •4 BMI of 18.5 to 30 and body weight more than 50 kg
- •5 Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 7 days after the last dose of assigned treatment
- •6 Indian citizenship
排除标准
- •1 A participant who has participated in other studies including non medicinal studies involving investigational products within 30 days before dosing
- •2 A participant who is pregnant as confirmed by a positive hCG laboratory test or intending to become pregnant over the duration of the study
- •3 A participant who is breastfeeding
- •4 A participant with known or suspected intolerance or hypersensitivity to the study materials or closely related compounds or any of their stated ingredients or excipients in the products
- •5 A participant unwilling or unable to comply with lifestyle considerations
- •6 Diagnosis of long QT syndrome or QTc more than 450 msec for males and more than 470 msec for females at screening
- •7 A participant with evidence or history of clinically significant laboratory abnormality within the last 5 years that may increase the risk associated with study participation
- •8 Any surgical or medical condition which may significantly alter the pharmacokinetics of any drug substance
- •9 History of major gastrointestinal tract surgery
- •10 History of inflammatory bowel disease
- •11 Positive results in any of the virology tests done
- •12 Allergy to skin disinfecting agents, tape, or latex rubber, whenever appropriate substitutions cannot be applied or in the opinion of the Investigator opinion may pose a risk to the candidate
- •13 Any condition not identified in the protocol that in the opinion of the Investigator would confound the evaluation and interpretation of the study data or may put the participant at risk
- •14 Use of any medication within 2 weeks prior to admission to the unit or within less than 10 times the elimination half life of the respective drug or is anticipated to require any concomitant medication during that period or at any time throughout the study
研究者
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