Clinical Study to Evaluate the Safety and Tolerability of in Healthy Human Volunteers for a period of 3 months for the safety endpoints.

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Healthy adult male or female subjects aged between 18- 45 years.

2. Subjects with normal body mass index (BMI) 18.5-24.9 kg/m2

3. Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests.

4. Subjects who refrain from taking any oral/ topical medication at least 15 days prior and during the study period. (SOS medications to be allowed during the study for any specific medical condition like paracetamol for fever).

5. Subjects who have not participated in any other similar clinical study within the last 3 months of screening.

6. Women of child-bearing potential using reliable method of contraception within 2 months of screening and willing to adopt the reliable and validated contraceptive methods throughout the study period to avoid pregnancy.

7. Subjects willing to sign informed consent and follow the study procedure.

Exclusion Criteria

1. Subjects with known clinically significant nervous, endocrinal, cerebrovascular, cardiovascular, respiratory, renal, genitourinary, congenital or any other systemic disorder that can interfere with the study conduct and outcome in the opinion of the Investigator (Subject with any chronic medical condition under control to be also excluded).

2. Subjects with known history of GIT disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score more than 1 for any one of the 15 questions to be excluded).

3. Subjects with known fatty liver disease grade 2 or more, history of chronic liver disease (like ALD/ NAFLD/MAFLD, chronic viral hepatitis like hepatitis B, C).

4. Subjects with known history of acute liver disease like acute hepatitis, within 6 months prior to the study.

5. Subjects with history of major surgery (like cholecystectomy) and major procedures like MRCP, ERCP.

6. Subjects with pre-existing systemic diseases (auto immune disorders, hormonal replacement etc.) necessitating long-term medications.

7. Subjects with any current infections (bacterial, fungal, viral) at the time of

screening as determined by the investigator.

8. Pregnant or lactating women (as assessed by UPT & history of amenorrhea).

9. Male subjects who is not willing to use adequate/ validated contraception and not willing to refrain from donating sperm from first admission to the study until 90 days after the follow-up visit.

10. Subjects who are not willing to refrain from alcohol or smoking from 48 hours prior and during the study.

11. Subjects with history of drug addiction or alcohol abuse within 5 years prior to the study

12. Subjects who undergo strenuous exercise within 7 days prior and during the study.

13. Any other reason (physical, psychological, or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.

14. Subjects with known history or present condition of allergic response (like urticaria) to the study drug or any ingredients in the investigational product.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and efficacy Assessment of GI (Gastrointestinal) tolerability through GSRS <br/ ><br>(Gastrointestinal Symptom Rating Scale)Timepoint: Day 1 & Day 7

Secondary Outcome Measures