CTRI/2018/01/011259
Completed
Phase 1
A Phase-I, Dose Escalation Study to evaluate safety, tolerability and pharmacokinetic of ICB-014-A002 capsule in healthy adult volunteers.
Indian Institute of Integrative Medicine Council of Scientific Industrial Research0 sites38 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Indian Institute of Integrative Medicine Council of Scientific Industrial Research
- Enrollment
- 38
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy adult volunteers within age group of 18\-55 years.
- •2\. BMI in the range of 18\.50 â?? 24\.90 kg/m2 (both inclusive).
- •3\. Volunteers with an abnormal clinical chemistry, hematology or urinalysis results that is considered clinically significant by the investigator or the sponsor.
- •4\. Free of any acute/chronic illness and should not be on treatment for any prior illness.
- •5\. Non\-smokers or non\-alcoholic.
- •6\. Volunteer must be willing to provide written informed consent and comply with the requirements of the study.
Exclusion Criteria
- •1\. Volunteer incapable of understanding the informed consent process / procedure.
- •2\. Volunteer who have taken a PPI or a H2 blocker or prokinetic agent or any other gastroprotective agent within seven days of screening
- •3\. Volunteer with known history of any clinically significant medical diseases, hematology, biochemistry or urine analysis will be excluded from the study unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study.
- •4\. Volunteer who have taken any enzymes modifying drugs within the past four weeks prior to start of clinical study
- •5\. Volunteer who have taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study.
- •6\. Investigations with blood samples of the volunteer shows presence of disease marker of HIV 1 and 2, Hepatitis B \& C viruses.
- •7\. Positive test for urinary screen testing of drugs of abuse.
- •8\. Volunteer found positive for alcohol breath test.
- •9\. Xanthine\-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing or alcoholic products consumption within 48 hours prior to the dosing.
- •10\. Volunteer who have consumed â??Grape fruitâ?? or its juice within 72 hours prior to dosing of each period.
Outcomes
Primary Outcomes
Not specified
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