Pharmacokinetic Study for PCA Derivate Formulations (PCA 1)

Hadassah Medical Center

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: PCA

Study type: Interventional

Funder types: Other

Identifiers

NCT00729729

PCA pharmacokinetics 1

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: PCA

Drug: PCA

Drug: PCA

2

Experimental group

Description:

Slow release PCA derivative

Treatment:

Drug: PCA

Drug: PCA

Drug: PCA

3

Experimental group

Description:

Slow release PCA derivative higher dose

Treatment:

Drug: PCA

Drug: PCA

Drug: PCA