PharmacokineticsPhase 1NCT04161404
Pharmacometabolomics of Andrographis Paniculata And Metformin In Healthy Volunteers Under Fasting Condition
A Phase 1 study testing Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules, Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg and Metformin (Glucophage) 1000mg in people with Pharmacokinetics and Molecular Mechanisms of Pharmacological Action, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Molecular Mechanisms of Pharmacological Action
- What is being tested?
- Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules, Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg and Metformin (Glucophage) 1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteMalaysia
- Study dates
- 21 Aug 2019to 31 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sex: male
- 18 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- 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.
- Inability to communicate or co-operate.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Clinical Investigation Centre, University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Krisna Veni Balakrishnan, 60379494932, cic_staff@um.edu.my
Luqman Ibrahim, MD
About this study
Official title: 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
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.
Read the detailed 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.
- Being tested
- Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules, Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg, Metformin (Glucophage) 1000mg
- Keywords
- Pharmacometabolomic, Metformin, Andrographis paniculata, Metabolomics, Phase 1, Healthy volunteers, Herbal Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsulesDrug
Also called Product name: Shine Hempedu Bumi
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) 2000mgDrug
Also called Product name: Shine Hempedu Bumi
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) 1000mgDrug
Also called Brand name: Glucophage
Metformin is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design. Receives: Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules; Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg; Drug: Metformin (Glucophage) 1000mg |
| Period 2 | Experimental | Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design. Receives: Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules; Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg; Drug: Metformin (Glucophage) 1000mg |
| Period 3 | Experimental | Subjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design. Receives: Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules; Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg; Drug: Metformin (Glucophage) 1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-24 hours
Cmax of Andrographis paniculata
Maximum plasma concentration of Andrographis paniculata after single dose oral administration.
Measured: 0-24 hours
Tmax of Andrographis paniculata
Time until Cmax of Andrographis paniculata is reached after single dose oral administration.
Measured: 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
Measured: 0-24 hours
Cmax of Metformin
Maximum plasma concentration of Metformin after single dose oral administration.
Measured: 0-24 hours
Tmax of Metformin
Time until Cmax of Metformin is reached after single dose oral administration.
Measured: 0-24 hours
Secondary outcomes (3)
Metabolic pathway of Andrographis paniculata
Pre-dose and post-dose samples will be analysed using LCMSMS. Normalization, log-transformation and center scaling will then apply to batches of chromatograms. Global metabolomics analyses will be performed to identify significant endogenous metabolites between post-dose and pre-dose samples using T-Test, Principal Component Analysis, Partial Least Square Discriminant Analysis. Annotations of significant compounds will be perform using METLIN database. The significant compounds will lead to prediction of relevant metabolomic pathway from Human Metabolome Database/ Kyoto Encyclopedia of Gene and Genome pathway for Andrographis paniculata.
Measured: 24 hours
Metabolic pathway of Metformin
Pre-dose and post-dose samples will be analysed using LCMSMS. Normalization, log-transformation and center scaling will then apply to batches of chromatograms. Global metabolomics analyses will be performed to identify significant endogenous metabolites between post-dose and pre-dose samples using T-Test, Principal Component Analysis, Partial Least Square Discriminant Analysis. Annotations of significant compounds will be perform using METLIN database. The significant compounds will lead to prediction of relevant metabolomic pathway from Human Metabolome Database/ Kyoto Encyclopedia of Gene and Genome pathway for Metformin.
Measured: 24 hours
Adverse drug reaction
Number of subjects with adverse drug reaction
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start21 Aug 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open label, block-randomized, three-period, crossover, single dose oral administration of investigational products. Subjects will undergo at least 7 days washout period.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Sponsor
- Investigators
- Khim Boon Tee, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161404
- Sponsor's protocol ID
- P1-PKPD-Metabolomic
- Status last verified
- Dec 2019
- First submitted
- 4 Nov 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04161404
- Acronym / sponsor ID
- P1-PKPD-Metabolomic
- Keywords
- Pharmacometabolomic, Metformin, Andrographis paniculata, Metabolomics, Phase 1, Healthy volunteers, Herbal Medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open label, block-randomized, three-period, crossover, single dose oral administration of investigational products. Subjects will undergo at least 7 days washout period.
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules, Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg, Drug: Metformin (Glucophage) 1000mgSubjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design. |
| Period 2 | Experimental | Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules, Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg, Drug: Metformin (Glucophage) 1000mgSubjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design. |
| Period 3 | Experimental | Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules, Drug: Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg, Drug: Metformin (Glucophage) 1000mgSubjects will randomized to either of the intervention drug in a ratio of 1:1:1 following three period, cross-over study design. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sex: male
- 18 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsulesAlso: Product name: Shine Hempedu BumiAndrographis 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. | Drug | Period 1, Period 2, Period 3 |
| Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mgAlso: Product name: Shine Hempedu BumiAndrographis 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. | Drug | Period 1, Period 2, Period 3 |
| Metformin (Glucophage) 1000mgAlso: Brand name: GlucophageMetformin is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects | Drug | Period 1, Period 2, Period 3 |
Primary outcome
Area under the plasma concentration-time curve (AUC) of Andrographis paniculata
Time frame: 0-24 hours
Area under the plasma concentration curve of Andrographis paniculata from administration to 24 hours
Cmax of Andrographis paniculata
Time frame: 0-24 hours
Maximum plasma concentration of Andrographis paniculata after single dose oral administration.
Tmax of Andrographis paniculata
Time frame: 0-24 hours
Time until Cmax of Andrographis paniculata is reached after single dose oral administration.
Area under the plasma concentration-time curve (AUC) of Metformin
Time frame: 0-24 hours
Area under the plasma concentration curve of Metformin from administration to 24 hours
Cmax of Metformin
Time frame: 0-24 hours
Maximum plasma concentration of Metformin after single dose oral administration.
Tmax of Metformin
Time frame: 0-24 hours
Time until Cmax of Metformin is reached after single dose oral administration.
3 secondary outcomes
Metabolic pathway of Andrographis paniculata
Time frame: 24 hours
Metabolic pathway of Metformin
Time frame: 24 hours
Adverse drug reaction
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Medical Research Ethics Committee, University Malaya Medical CentreLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khim Boon Tee principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules, Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg and Metformin (Glucophage) 1000mg in people with Pharmacokinetics and Molecular Mechanisms of Pharmacological Action, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krisna Veni Balakrishnan (60379494932, krisna.veni@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve (AUC) of Andrographis paniculata (time frame: 0-24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.