Pharmacokinetic Study for PCA Derivate Formulations

Hadassah Medical Organization30 enrolled

Overview

A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

PCADRUG

Placebo tablet, once

PCADRUG

PO, 700mg, once

PCADRUG

PO, 1000mg, once

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who have completed the informed consent process culminating with written informed consent by the subject. * Males * Age 18-45 years * Abstinence from alcohol for 1 week prior to the study * Non smoking * BMI \> 19 and \< 30 * No history or evidence of significant * cardiovascular, * hepatic, * renal, * hematopoietic, * gastrointestinal disease, * endocrine, * metabolic, * psychiatric * psychological disorders * Normal physical examination * Within +/- 10% of normal values in laboratory examinations Exclusion Criteria: * Subjects who suffer from a current medical condition. * Subjects who smoke. * Subjects who drink \> 20 grams of alcohol per day. * Subjects who take prescription medication. * Subjects with an abnormality in screening blood tests * Known sensitivity to any ingredients in the study drug

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

Outcomes

Primary Outcomes

PCA derivate blood levels

Time frame: 24 hours

Data from ClinicalTrials.gov

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