| CTRI Number |
CTRI/2020/09/027660 [Registered on: 08/09/2020] Trial Registered Prospectively |
| Last Modified On: |
09/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Ayurveda |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Clinical study to check the safety and tolerability of ATRICOV 452 capsule of 500 mg in healthy adult human subjects. |
|
Scientific Title of Study
|
A Prospective, Interventional, Open label, Phase 1, single-centre, single fasting dose study to evaluate the safety and tolerability of ATRICOV 452 capsule of 500 mg in healthy adult human subjects. |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| CBio/CR/APPL/2108/114, version 01 dated 21 Aug 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreerangarajan HJ |
| Address |
#16 and 18, ICBio Tower
Yelahanka Main Road
Chikkabettahalli
Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
pi.mail@icbiocro.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Harish S |
| Address |
#16 and 18, ICBio Tower
Yelahanka Main Road
Chikkabettahalli
Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Harish S |
| Address |
#16 and 18, ICBio Tower
Yelahanka Main Road
Chikkabettahalli
Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Atrimed Pharmaceutical Pvt. Ltd.
No. 29-30, Prestige Meridian, 14th floor, Tower 2, MG Road,
Bengaluru-560001 Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Atrimed Pharmaceutical Pvt Ltd |
| Address |
No. 29-30, Prestige Meridian, 14th floor, Tower 2, MG Road,
Bengaluru-560001 Karnataka, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreerangarajan H J |
ICBio Clinical Research Pvt. Ltd. |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore
|
9900111997
pi.mail@icbiocro.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal, healthy, adult, male human subject of 18-45 years of age. |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
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. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Normal, healthy, adult, male human subject
of 18-45 years of age.
2. Body mass index in the range of 18.50 –
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.
|
|
| ExclusionCriteria |
| Details |
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
blood–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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
• To evaluate the safety of investigational products
Skin:
Neurological:
Musculoskeletel:
Gastrointestinal:
Liver:
Kidney:
Endocrine system and metabolism
Cardiovascular:
Haematopoietic:
|
Day 1 to day 7 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
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. |
Day 1 to day 7 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/09/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Brief Summary
|
“A
Prospective, Interventional, Open label, Phase
1, single-centre, single fasting dose study to evaluate the safety and
tolerability of ATRICOV 452 capsule of 500 mg in healthy adult human
subjects.” Around 13 days (Screening 2 to 3 days + dosing and
safety evaluation 2 to 3 days and follow up after 7 days) Total of 24 healthy adult human subjects will be
enrolled for the study. |
