Paxil CR Bioequivalence Study Brazil
Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablet With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fasted Administration in Healthy Volunteers for Both Genders.
연구 개요
상세 설명
Full title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fasted administration in healthy volunteers for both genders.
The study is open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).
The population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are not restrictions regarding the ethnic group.The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of concentration of drug in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each fasting period. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Minas Gerais
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Belo Horizonte, Minas Gerais, 브라질, 30110-014
- GSK Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
EXCLUSION CRITERIA:
- hypersensitivity to the study drug or to compounds chemically related;
- history of serious adverse events;
- concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;
- History of liver, heart, gastrointestinal or renal illness;
- ECG findings not recommended according to the investigator judgement;
- The volunteer ingests more than 5 cups of coffee or tea a day.
INCLUSION CRITERIA:
- Man and woman (since they are not pregnant or breastfeeding);
- age between 18 and 40 years;
- non-smoker and not addict;
- mass index between 18,5 and 27;
- good health conditions or without significant illness, by judgement of a legally qualified professional;
- sign the informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Paxil CR Reference
Reference drug administration followed by test drug administration
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Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
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활성 비교기: Paxil CR Test
Test drug administration followed by Reference drug administration
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Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Area Under the Curve_steady-state
기간: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC).
The AUC_steady-state (ss) is the area under the curve during the steady-state period.
The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
ng, nanogram; h, hour; ml, milliliter.
ng.h/ml, nanograms per hour per milliliter.
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Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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Cmin_steady-state
기간: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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Cmin_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state.
Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.
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Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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Cmax_steady-state
기간: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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Cmax_steady-state (ss) is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state.
Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
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Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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Test formulation에 대한 임상 시험
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PATHUnited States Agency for International Development (USAID); Kintampo Health Research Centre...완전한
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National Institute of Respiratory Diseases, Mexico완전한
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University Hospital, Bordeaux알려지지 않은
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EMD Serono완전한
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Texas Cardiac Arrhythmia Research Foundation알려지지 않은