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

University of Malaya

Status and phase: Unknown; Phase 1

Conditions: Molecular Mechanisms of Pharmacological Action; Pharmacokinetics

Treatments: Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules; Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg; Drug: Metformin (Glucophage) 1000mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04161404

P1-PKPD-Metabolomic

Details and patient eligibility

About

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.

Full description

This is a phase 1, open label, randomized, three period, crossover, single dose oral administration of Andrographis Paniculata 1000mg, 2000mg and Metformin 1000mg clinical trial in healthy volunteers under fasting condition. Approximately 18 healthy volunteers will be enrolled into this study.

The healthy volunteers will be screened for inclusion and exclusion criteria. Eligible subjects will be enrolled into either Metformin 1000mg tablet, Andrographis Paniculata 1000mg or 2000mg capsule in a ratio of 1:1:1 in period 1 for single dose oral administration. Subjects will then undergo a washout period of at least 7 days. After the washout period, subjects will crossover over to another investigational product according to the randomization sequence.

Subjects will fast overnight prior to dosing. The volunteers will be admitted to Clinical Investigation Center ward at 7 am in the morning and will confine in air-conditioning environment with beds and chairs. The means during the stay at CIC ward will be provided to the subjects. The dosing will be performed at 8am. A series of plasma will be collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours post-dose. Urine samples will be collected at 0, 0-4 hours, 4-8 hours and 8-12 hours.

A safety follow-up call will be made to subjects to record any adverse events that occurred post-dosing within 1 week.

Enrollment: 18 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Period 1

Experimental group

Description:

Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.

Treatment:

Drug: Metformin (Glucophage) 1000mg

Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg

Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules

Period 2

Experimental group

Description:

Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.

Treatment:

Drug: Metformin (Glucophage) 1000mg

Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg

Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules

Period 3

Experimental group

Description:

Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.

Treatment:

Drug: Metformin (Glucophage) 1000mg

Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg

Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules