Pharmacometabolomics of Andrographis Paniculata And Metformin In Healthy Volunteers Under Fasting Condition

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This study is a phase 1, open label, randomized, three-way crossover, single dose, oral- administration of Andrographis paniculata and Metformin in healthy volunteers under fasting condition. The study will demonstrate the pharmacokinetics profile and pharmacodynamic through metabolic pathway analysis for Andrographis paniculata and Metformin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Malaya
• Collaborators: Ministry of Health, Malaysia; National Pharmaceutical Regulatory Agency
• Treatments: Andrographolide; Metformin

Criteria

Inclusion Criteria:

1. Sex: male

2. 18 to 45 years of age (inclusive both)

3. BMI 18.5 - 29.5 kg/m2 (inclusive both) with minimum weight of 50kg

4. Non-smokers

5. Legible and willing to provide written informed consent.

Exclusion Criteria:

1. Volunteers suffering from any chronic illness such as arthritis, asthma, etc.

2. History of pre-existing bleeding disorder.

3. Clinically relevant abnormalities in the results of the laboratory screening evaluation.

4. Clinically significant abnormal electrocardiogram (ECG).

5. Positive HIV or positive hepatitis B or C in screening test or no known other hepatitis infection.

6. History of significant blood loss due to any reason, including blood donation in the past 3 months.

7. Participation in any study within past 3 months

8. History of alcohol or drug abuse

9. History of consumption of prescribed medication since last 14 days or Over-the-counter medication/ herbal remedies since last 7 days before beginning of the study.

10. Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mmHg or more than 89 mmHg.

11. Pulse rate less than 60/minutes or more than 100/minute unless deem not clinically significant by investigator.

12. Oral temperature more than 37.5 degree Celsius.

13. History of allergy to the investigational product or any drug chemically similar to the drug under investigation.

14. Recent history of kidney or liver dysfunction.

15. Volunteers suffering from any psychiatric (acute or chronic) disorder.

16. Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.

17. Inability to communicate or co-operate.