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Trial record 14 of 734 for:    warfarin

Effect of BIA 3-202 on the Pharmacokinetics and Pharmacodynamics of Warfarin

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ClinicalTrials.gov Identifier: NCT02779348
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
The purpose of this study is to determine whether multiple-dose administration of nebicapone affects the pharmacokinetics of warfarin.

Condition or disease Intervention/treatment Phase
Healthy Drug: BIA 3-202 Drug: warfarin Phase 1

Detailed Description:

Study design and methodology:

This was a single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study consisted of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects received nebicapone 200 mg thrice-daily (tid) for 9 days, and a warfarin 25 mg single-dose concomitantly with the morning dose of nebicapone on Day 4. In the other period, a warfarin 25 mg single-dose was administered alone. Warfarin pharmacokinetic and pharmacodynamic profiles were characterised following warfarin dosing.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of BIA 3-202 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Volunteers
Study Start Date : September 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Nebicapone plus warfarin
BIA 3-202 200 mg tid + Warfarin 25 mg
Drug: BIA 3-202
Nebicapone tablets 200 mg
Other Name: Nebicapone

Drug: warfarin
Varfine® 5 mg (warfarin 5 mg) tablets

Experimental: Warfarin
Warfarin 25 mg
Drug: warfarin
Varfine® 5 mg (warfarin 5 mg) tablets




Primary Outcome Measures :
  1. Mean Cmax of S-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Maximum observed plasma drug concentration (Cmax)

  2. Mean tmax of S-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Time of occurrence of Cmax (tmax)

  3. Mean AUC0-144 of S-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Area under the plasma concentration-time curve (AUC) from time zero to 144 h post-warfarin dose (AUC0-144), calculated by the linear trapezoidal rule

  4. Mean λz of S-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Apparent terminal rate constant calculated by log-linear regression of the terminal segment of the concentration versus time curve (λz)

  5. Mean t1/2 of S-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Apparent terminal half-life, calculated from ln 2/λz (t1/2).

  6. Mean Cmax of R-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Maximum observed plasma drug concentration (Cmax)

  7. Mean tmax of R-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Time of occurrence of Cmax (tmax)

  8. Mean AUC0-144 of R-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Area under the plasma concentration-time curve (AUC) from time zero to 144 h post-warfarin dose (AUC0-144), calculated by the linear trapezoidal rule

  9. Mean λz of R-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Apparent terminal rate constant calculated by log-linear regression of the terminal segment of the concentration versus time curve (λz)

  10. Mean t1/2 of R-warfarin [ Time Frame: before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose ]
    Apparent terminal half-life, calculated from ln 2/λz (t1/2).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:

  • Male or female subjects aged between 18 and 45 years, inclusive.
  • Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
  • Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
  • Clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
  • Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
  • Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
  • Non-smokers or who smoked ≤ 10 cigarettes or equivalent per day.
  • Able and willing to give written informed consent.
  • (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
  • (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

Subjects were not eligible for entry into the study if they fulfilled the following exclusion criteria:

  • Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
  • Clinically relevant surgical history.
  • Personal or family history of haemostatic disorder.
  • Personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.
  • Any abnormality in the coagulation tests.
  • Any abnormality in the liver function tests.
  • A history of relevant atopy or drug hypersensitivity.
  • History of alcoholism or drug abuse.
  • Consumed more than 14 units of alcohol a week.
  • Significant infection or known inflammatory process at screening or admission to each treatment period.
  • Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
  • Had used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
  • Had previously received BIA 3-202.
  • Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
  • Had participated in more than 2 clinical trials within the 12 months prior to screening.
  • Had donated or received any blood or blood products within the 3 months prior to screening.
  • Vegetarians, vegans or had medical dietary restrictions.
  • Cannot communicate reliably with the investigator.
  • Unlikely to co-operate with the requirements of the study.
  • Unwilling or unable to gave written informed consent.
  • (If female) She was pregnant or breast-feeding.
  • (If female) She was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier, intra-uterine device or abstinence) or she used oral contraceptives.

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): NCT02779348


Locations
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Portugal
Human Pharmacology Unit (UFH),
S. Mamede do Coronado, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02779348     History of Changes
Other Study ID Numbers: BIA-3202-112
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bial - Portela C S.A.:
Nebicapone
Warfarin
Additional relevant MeSH terms:
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Warfarin
Anticoagulants