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Minocycline Bioequivalence Study

NCT01938508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-11-18

No results posted yet for this study

Summary

This study compared the bioavailability of two formulations 100 mg (one capsule or other respectively) of each one of the products, of Minocycline, under fasting conditions, in healthy Mexican volunteers of both sexes. The single dose study under fasting (10 hours prior to study) conditions, cross, with two treatments, two periods, two sequences (2x2) randomized sequence, balanced, and with a washout period of at least 7 days between each dose, in 24 healthy volunteers.

Conditions

  • Skin Diseases

Interventions

DRUG

Minocycline

minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline

Sponsors & Collaborators

  • CECYC (Center of Scientific and Clinical Studies, CRO)

    collaborator UNKNOWN

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Companies

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 NCT01938508 on ClinicalTrials.gov