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

NCT04161404 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-12-26

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics
  • Molecular Mechanisms of Pharmacological Action

Interventions

DRUG

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.

DRUG

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.

DRUG

Metformin (Glucophage) 1000mg

Metformin is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV

  • University of Malaya

    lead OTHER

Principal Investigators

  • Khim Boon Tee · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04161404 on ClinicalTrials.gov