Pharmacometabolomics of Andrographis Paniculata And Metformin In Healthy Volunteers Under Fasting Condition
NCT ID: NCT04161404
Last Updated: 2019-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2019-08-21
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Period 1
Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.
Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules
Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg
Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
Metformin (Glucophage) 1000mg
Metformin is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects
Period 2
Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.
Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules
Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg
Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
Metformin (Glucophage) 1000mg
Metformin is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects
Period 3
Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.
Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules
Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg
Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
Metformin (Glucophage) 1000mg
Metformin is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects
Interventions
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Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules
Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg
Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
Metformin (Glucophage) 1000mg
Metformin is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
MALE
Yes
Sponsors
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Ministry of Health, Malaysia
OTHER_GOV
University of Malaya
OTHER
Responsible Party
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Principal Investigators
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Khim Boon Tee
Role: PRINCIPAL_INVESTIGATOR
University of Malaya
Locations
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Clinical Investigation Centre, University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Krisna Veni Balakrishnan
Role: primary
Related Links
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Medical Research Ethics Committee, University Malaya Medical Centre
Other Identifiers
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P1-PKPD-Metabolomic
Identifier Type: -
Identifier Source: org_study_id