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Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects

An Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol)

NCT03095105•Bial - Portela C S.A.

View on ClinicalTrials.gov

Summary

the purpose of the study was to the compare pharmacokinetic profile of BIA 6-512 in healthy elderly subjects versus healthy young subjects after single and repeated oral administration of 200 mg BIA 6-512.

Detailed Description

Single-centre, open-label study in healthy young (18-40 years) and elderly (65 years or older) subjects. The study consisted of a single-dose phase followed by a repeated dose phase (3 times daily, at 8-h intervals). Subjects were admitted on the day prior to the first dose (Day 1). On day 1, a single dose of 200 mg BIA 6-512 (Dose 1) was administered in the morning. On day 2, the repeated dose phase started 24 h post first dosing. In the repeated dose phase (Doses 2 to 8) subjects received 200 mg BIA 6-512 every 8 hours until the morning of day 4 (approximately 72 hours post first dosing).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female subjects aged between 18 and 40 years, inclusive (young); or male or female subjects aged 65 years or more (elderly).
•Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
•Healthy as determined by an inter¬view, pre-study medical history, physical examination, vital signs, neurological examination and 12-lead ECG; clinical laboratory test results clinically acceptable at screening and admission.
•Negative tests for HBsAg, anti-HCVAb, anti-HIV-1 Ab and anti-HIV-2 Ab at screening.
•Negative screen for drugs of abuse at screening and admission.
•Informed consent signed by the subject.
•Co-operative and available for the entire study.
•Abstinence from alcohol for 48 hours prior to admission (as stated by subject). An alcohol breath test performed at screening and at admission to the clinic had to be negative.
•Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day.
•If female, in the young group: 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; and she had a negative urine pregnancy test at screening and admission.

Exclusion Criteria

•Evidence in the subject's medical history or in the medical exa¬mina¬tion of any clinically significant respiratory, hepatic, renal, gastrointesti¬nal, haematological, lymphatic, neurological, car¬diovascu¬lar, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue or other significant acute or chronic abnormalities which might influence either the safety of the subject or the ab¬sorption, dis¬tribution, meta¬bolism or excretion of the active agent under investigation.
•History of relevant drug or food hypersensitivity.
•Significant infection or known inflammatory process on screening or admission.
•Acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
•Regular use of any medication within four weeks prior to study admission (self-medication or prescription).
•Single use of any medication (including OTC) that was not expressly permitted within two weeks prior admission to the stu¬dy.
•Abuse of alcohol (equiv¬alent to more than 35 g ethanol per day).
•Vegetarians, vegans or subjects who had medical dietary restrictions.
•History of alcoholism or drug abuse.
•Participation in a clinical investigation within two months prior to screening.
+7 more criteria

Locations (1)

Scope International AG

Hamburg, Germany

Key Dates

Start Date

January 24, 2006

Primary Completion Date

March 2, 2006

Completion Date

March 2, 2006

Last Updated

March 30, 2017

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

200 mg BIA 6-512

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects

Inclusion Criteria

Exclusion Criteria

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