Pharmacometabolomics of Andrographis Paniculata And Metformin In Healthy Volunteers Under Fasting Condition
A Phase 1, Open Label, Randomized, Three-Period, Crossover, Single Dose Oral Administration Of Andrographis Paniculata And Metformin Clinical Trial In Healthy Volunteers Under Fasting Condition
1 other identifier
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2019
CompletedFirst Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedDecember 26, 2019
December 1, 2019
4 months
November 4, 2019
December 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Area under the plasma concentration-time curve (AUC) of Andrographis paniculata
Area under the plasma concentration curve of Andrographis paniculata from administration to 24 hours
0-24 hours
Cmax of Andrographis paniculata
Maximum plasma concentration of Andrographis paniculata after single dose oral administration.
0-24 hours
Tmax of Andrographis paniculata
Time until Cmax of Andrographis paniculata is reached after single dose oral administration.
0-24 hours
Area under the plasma concentration-time curve (AUC) of Metformin
Area under the plasma concentration curve of Metformin from administration to 24 hours
0-24 hours
Cmax of Metformin
Maximum plasma concentration of Metformin after single dose oral administration.
0-24 hours
Tmax of Metformin
Time until Cmax of Metformin is reached after single dose oral administration.
0-24 hours
Secondary Outcomes (3)
Metabolic pathway of Andrographis paniculata
24 hours
Metabolic pathway of Metformin
24 hours
Adverse drug reaction
3 weeks
Study Arms (3)
Period 1
EXPERIMENTALSubjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.
Period 2
EXPERIMENTALSubjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.
Period 3
EXPERIMENTALSubjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design.
Interventions
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.
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 is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects
Eligibility Criteria
You may qualify if:
- Sex: male
- to 45 years of age (inclusive both)
- BMI 18.5 - 29.5 kg/m2 (inclusive both) with minimum weight of 50kg
- Non-smokers
- Legible and willing to provide written informed consent.
You may not qualify if:
- Volunteers suffering from any chronic illness such as arthritis, asthma, etc.
- History of pre-existing bleeding disorder.
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal electrocardiogram (ECG).
- Positive HIV or positive hepatitis B or C in screening test or no known other hepatitis infection.
- History of significant blood loss due to any reason, including blood donation in the past 3 months.
- Participation in any study within past 3 months
- History of alcohol or drug abuse
- 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.
- 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.
- Pulse rate less than 60/minutes or more than 100/minute unless deem not clinically significant by investigator.
- Oral temperature more than 37.5 degree Celsius.
- History of allergy to the investigational product or any drug chemically similar to the drug under investigation.
- Recent history of kidney or liver dysfunction.
- Volunteers suffering from any psychiatric (acute or chronic) disorder.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Malayalead
- Ministry of Health, Malaysiacollaborator
Study Sites (1)
Clinical Investigation Centre, University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khim Boon Tee
University of Malaya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 13, 2019
Study Start
August 21, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
December 26, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The information is available approximately in December 2020 or when the study is published. The data is available for 2 years.
- Access Criteria
- Kindly email to Tee Khim Boon for the above information.
We will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions by Medical Research Ethics Committee, University Malaya Medical Centre.