A Prospective, Multicenter, Open labeled, Randomized, phase IV clinical study to evaluate safety and efficacy of 2 FDCs of Zolpidem Tartrate IP 5 mg / 10 mg plus Melatonin 3 mg film coated tablets in subjects with Primary Insomnia and Sleep Disorder. - NI

inux Laboratories Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1. Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement behavior disorder, or narcolepsy.
•2. Self-reported usual daytime napping greater than equal to 1 hour per day, and greater than equal to 3 days per week.
•3. Caffeine consumption greater than equal to 600 mg per day.
•4. Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
•5. Travel greater than equal to 3 time zones within 1 week prior to the screening visit, or planned travel greater than equal to 3 time zones during study.
•6. Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
•7. AST and, or ALT greater than 2 times ULN and, or direct bilirubin greater than 1.5 times ULN. Except for the known history of Gilberts syndrome.
•8. Severe renal impairment Which is known or defined as estimated creatinine clearance less than 30 mL per min).
•9. History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
•10. Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject full participation in the study or compliance with the protocol.

发起方

inux Laboratories Private Limited