None listed
Conditions
Interventions
Intervention1: ATRICOV 452: After at least 10 hours of overnight fasting, a single dose, two capsules of 500 mg (total of 1000 mg dose) will be administered orally in sitting posture.
Control Interve
Sponsors
Atrimed Pharmaceutical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal, healthy, adult, male human subject of 18-45 years of age. 2. Body mass index in the range of 18.50 â?? 24.90 kg/m2. 3. Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 4. Willing to be available for the entire study period and to comply with protocol requirements. Normal haemoglobin between 13.8 to 17.2 grams per deciliter (g/dL). 5. Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in for the study.
Exclusion criteria
Exclusion criteria: 1.Women of child bearing age, children 2.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs. 3.History of severe infection or major surgery in the past 6 months. 4.History of Minor surgery or fracture within the past 3 months. 5. Significant history or current evidence of malignancy or chronic- infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 6.Any major illness or hospitalized within 90 days prior to the dosing. 7.Any other clinical condition like diarrhea or vomiting within three days prior to dosing. 8.Use of any depot injection or an implant of any drug within three months prior to dosing and throughout the study periods. 9.Use of any prescribed medication (including herbal medicines and vitamin supplements) within 30 days or within five half-lives of the drug, whichever is longer prior to dosing and throughout the study. 10.Use of any OTC products within 14 days or within five half-lives of the drug, whichever is longer prior to dosing and throughout the study. 11.History or presence of significant gastric or duodenal ulceration. 12.Use of any recreational drug or history of drug addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the safety of investigational products Skin: Neurological: Musculoskeletel: Gastrointestinal: Liver: Kidney: Endocrine system and metabolism Cardiovascular: Haematopoietic: Timepoint: Day 1 to day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance of IP will be evaluated by using attachment-1 ATRICOV 452 capsule of 500 mgmight have unknown side effects based on preclinical data so kindly record the based on your observation.Timepoint: Day 1 to day 7 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed