MedTrace Logo

PCO-02 - Safety and Pharmacokinetics Trial

NCT02637284 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-12-22

No results posted yet for this study

Summary

Phase I clinical trial in healthy volunteers to study safety and pharmacokinetics of BPC-157, a pentadecapeptide from gastric source.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Bepecin

Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics. Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.

DRUG

Placebo

Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group. Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.

Sponsors & Collaborators

  • Hospital Ángeles Tijuana

    collaborator UNKNOWN

  • PharmaCotherapia d.o.o.

    lead INDUSTRY

Principal Investigators

  • Rufino Menchaca, PhD · Hospital Ángeles Tijuana

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-02-29
Completion
2016-03-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637284 on ClinicalTrials.gov