CTRI/2020/01/023021尚未招募2 期
An Open label balanced randomized single dose two treatment two sequence two period crossover comparative bioavailability bioequivalence study of Glyceryl Trinitrate 0.5 mg sublingual tableets of Troikaa Pharmaceuticals Ltd india and Glyceryl Trinitrate 0.5 mg sublingual tablet of Actavis UK ltd UK in healthy adult human subjects under fasting condition
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
- •Subjects weight within normal range according to normal values for
- •Body Mass Index (18.50 to 30.00 kg/m2 (both inclusive)) with minimum
- •of 50 kg weight
- •Subjects with normal health as determined by personal medical and
- •medication history, clinical examination and laboratory examinations
- •within the clinically acceptable normal range
- •Subject having normal 2D Echocardiogram at screening
- •Subjects having clinically acceptable 12-lead electrocardiogram (ECG)
- •Subjects having clinically acceptable chest X-Ray (PA view)
- •Subjects having negative urine screen for drugs of abuse including
- •amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and
- •morphine, Methamphetamine, Codeine, Heroin and Phencyclidine
- •Non smokers and non-alcoholic subjects
- •Subjects having negative alcohol breath test
排除标准
- •Hypersensitivity to Glyceryl Trinitrate or related class of drugs or any of its
- •excipients or heparin
- •Any difficulty with sublingual drug administration.
- •History or presence of significant, oromucosal, cardiovascular, pulmonary,hepatic, renal, gastrointestinal, endocrine, immunological, dermatological,urogenital, neurological or psychiatric disease or disorder
- •Sitting blood pressure less than 110/70 mm Hg and pulse rate less than 50 or
- •more than 100 beats per minute at the time of screening
- •Presence of orthostatic hypotension
- •Use of any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to dosing of period 01
- •History or presence of alcoholism or drug abuse
- •History or presence of asthma, urticaria or other significant allergic reactions
- •History or presence of significant gastric and/or duodenal ulceration
- •History or presence of significant thyroid disease, adrenal dysfunction,
- •organic intracranial lesion such as pituitary tumor
- •History or presence of cancer or basal or squamous cell carcinoma
研究者
相似试验
已完成
Unknown
Open label, balanced, randomized, single dose, two treatment, two sequence, two period, crossover oral bioequivalence study in healthy adult human male subjects under fasting conditions.CTRI/2023/08/056242Adeptio Pharmaceutical Limited
招募中
Unknown
To evaluate the bioequivalence of Relugolix 120 mg tabletsCTRI/2024/07/070477BDR Pharmaceuticals Internationals Pvt Ltd
尚未招募
Unknown
An Open Label Balanced Randomized Single Dose Two Treatment Two Period Two Sequence Two Way Crossover Oral Bioavailability Study Of Vitamin C Sustained Release Sr Tablets 500 MgCTRI/2024/08/071926utriventia Limited
已完成
不适用
Oral comparative study of melatonin capsulesCTRI/2022/08/044837Dr Shefali Thanawala16
已完成
Unknown
To study the safety of curcumin capsulesCTRI/2023/10/058584GeneVec24