NCT01755611

Brief Summary

The aim of the study is to compare the bioavailability of two medications containing 100 mg of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin® is a registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is randomized, open, cross-over with two single administrations with two periods and two sequences with a wash-out period of 7 days between the periods. Subjects in the study will be 25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours after medication administration in each period. Plasma minocycline levels will be determined by HPLC method with UV detection with previously validated method. Minocycline concentration data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3 software. The log transformed pharmacokinetics parameters of test and reference medications will be compared calculating ratios and 90% confidence intervals. Any adverse event will be reported.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

8 days

First QC Date

December 19, 2012

Last Update Submit

June 21, 2017

Conditions

Skin Infections (Acne)

Keywords

MinocyclineMexicoAcnebioequivalence

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (CMAX) of drug minocycline

    Pharmacokinetics

    0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours postdose

  • Area under the plasma concentration versus time curve (AUC) of drug minocycline

    Pharmacokinetics

    0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours postdose

Study Arms (2)

A(reference)/B(test)

EXPERIMENTAL

initial administration of reference and cross-over to test

Drug: Minocycline 100mg

B(test)/A(reference)

EXPERIMENTAL

initial administration of test and cross-over to reference

Drug: Minocycline 100mg

Interventions

Minocycline 100mgDRUG

Test product

Also known as: MINOPAC® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.
A(reference)/B(test)B(test)/A(reference)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males 18-55 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent.

You may not qualify if:

  • Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.
  • Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation ≥ 450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

CellulitisAcne Vulgariscyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsAcneiform EruptionsSkin DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 24, 2012

Study Start

June 17, 2011

Primary Completion

June 25, 2011

Study Completion

June 25, 2011

Last Updated

June 22, 2017

Record last verified: 2017-06