Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Zolpidem Tartrate IP 5 mg with Melatonin 3 mg: Dose: Zolpidem Tartrate IP 5 mg with Melatonin 3 mg
Frequency: Once a day for 28 days
Route of administration: Oral
Control Intervention1:
Sponsors
Linux Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study mandated procedure. 2. Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT. 3. Body mass index between 18.5 to 32.0 kg per m2. 4. Insomnia disorder according to DSM 5 criteria. 5. Insomnia Severity Index score equal or grater than 15.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of 2 FDCs of Zolpidem Tartrate IP 5 mg and Melatonin 3 mg with Zolpidem Tartrate IP 10 mg and Melatonin 3 mg film coated tablets in subjects with Primary Insomnia & Sleep Disorder.Timepoint: Day1, Day 14, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of 2 FDCs of Zolpidem Tartrate IP 5 mg and Melatonin 3 mg with Zolpidem Tartrate IP 10 mg and Melatonin 3 mg film coated tablets in subjects with Primary Insomnia & Sleep Disorder.Timepoint: Day 1, Day 14, Day 28 | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
Linux Laboratories Private Limited
Outcome results
None listed