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Trial record 3 of 16 for:    Methyldopate hydrochloride

Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations

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ClinicalTrials.gov Identifier: NCT03210025
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited

Brief Summary:
The objective of the study is to compare the bioavailability of a generic product of methyldopa with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620). The plasma pharmacokinetic data of Methyldopa obtained from two formulations will be used to access the interchangeability of the products.

Condition or disease Intervention/treatment Phase
Healthy Drug: BF-Methyldopa 250mg Tablet Drug: Metopa Tab 250mg Phase 1

Detailed Description:
It is planned to enroll 16 to 30 healthy subjects, with an aim to obtain at least 12 evaluable subjects. The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, the subjects will be administered a single oral dose of 250mg methyldopa (one BF-Methyldopa Tablet 250mg or one Metopa Tab 250mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0h) and at 0.75 (45min), 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours post-dose. The plasma concentrations of methyldopa will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. Anylasis of variance (ANOVA) will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf using the General Linear Model. The two one-side tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax and to assess the bioequivalence of the two products.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-dose, two-treatment, two-period, two-sequence crossover
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Other
Official Title: Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : October 15, 2017
Actual Study Completion Date : October 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BF-Methyldopa Tablet 250mg
During the study session, healthy subjects will be administered a single dose of BF-Methyldopa Tablet 250mg after an overnight fast of approximately 10 hours
Drug: BF-Methyldopa 250mg Tablet
BF-Methyldopa 250mg Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Other Name: Methyldopa 250mg Tablet

Active Comparator: Metopa Tab 250mg
During the study session, healthy subjects administered a single dose of Metopa Tablet 250mg after an overnight fast of approximately 10 hours
Drug: Metopa Tab 250mg
Metopa Tab 250mg is manufactured by APT
Other Name: Methyldopa 250mg Tablet




Primary Outcome Measures :
  1. Cmax of Methyldopa [ Time Frame: 24 hours ]
  2. AUC of Methyldopa [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Tmax of Methyldopa [ Time Frame: 24 hours ]
  2. Elimination half-life (t1/2) of Methyldopa [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and non-pregnant female, 18 to 55 years of age
  • Body Mass Index between 18 to 27 kg/m2
  • Accessible vein for blood sampling
  • High probability for compliance and completion of the study
  • Female subjects must agree to practice abstinence or take effective contraceptive methods to prevent pregnancy from the start of screening until two weeks of last dose administration.

Exclusion Criteria:

  • Clinical significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
  • Clinical significant abnormality in physical examination, vital signs, ECG evaluation, urine test, blood chemistry or haematological test
  • Tobacco use in any forms
  • Regular consumer of alcohol
  • Blood donation within 4 weeks prior to the start of the study
  • Use of Methyldopa within 4 weeks before the study
  • Use of antihypertensive medications within 4 weeks before the study
  • Volunteer in any other clinical drug study within 2 months prior to this study
  • Hypersensitivity to Methyldopa or other drugs in its class
  • History of drug abuse in any form
  • Female subjects who are breastfeeding or pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210025


Locations
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Hong Kong
Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Chinese University of Hong Kong
Investigators
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Principal Investigator: Zhong Zuo School of Pharmacy, The Chinese University of Hong Kong
Study Director: Riza Ozaki Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Study Director: Brian Tomlinsion Department of Medicine and Therapeutics, The Chinese University of Hong Kong

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Responsible Party: Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
ClinicalTrials.gov Identifier: NCT03210025     History of Changes
Other Study ID Numbers: BABE-P15-096
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Methyldopa
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action