Clinical study to check the safety and tolerability of ATRICOV 452 capsule of 500 mg in healthy adult human subjects.
- Registration Number
- CTRI/2020/09/027660
- Lead Sponsor
- Atrimed Pharmaceutical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To evaluate the safety of investigational products <br/ ><br>Skin: <br/ ><br>Neurological: <br/ ><br>Musculoskeletel: <br/ ><br>Gastrointestinal: <br/ ><br>Liver: <br/ ><br>Kidney: <br/ ><br>Endocrine system and metabolism <br/ ><br>Cardiovascular: <br/ ><br>Haematopoietic: <br/ ><br>Timepoint: Day 1 to day 7
- Secondary Outcome Measures
Name Time Method Tolerance of IP will be evaluated by using attachment-1 <br/ ><br>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