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Bioequivalence Minocycline Bioequivalence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01755611
First received: December 19, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Skin Infections (Acne)
 Drug: Minocycline 100mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioequivalence Study Between Two Medications for Oral Administration of Minocycline in 100 mg Oral Solids in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Peak Plasma Concentration (CMAX) of drug minocycline [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Area under the plasma concentration versus time curve (AUC) of drug minocycline [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Pharmacokinetics


Enrollment: 25
Study Start Date: June 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A(reference)/B(test)
initial administration of reference and cross-over to test
 Drug: Minocycline 100mg
Test product
Other Names:
  • MINOPAC® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER
  • S.A. DE C.V.
Drug: Minocycline 100mg
Reference product
Other Name: MINOCIN® is a registered trademark of Wyeth Holdings Corporation
Experimental: B(test)/A(reference)
initial administration of test and cross-over to reference
 Drug: Minocycline 100mg
Test product
Other Names:
  • MINOPAC® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER
  • S.A. DE C.V.
Drug: Minocycline 100mg
Reference product
Other Name: MINOCIN® is a registered trademark of Wyeth Holdings Corporation

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755611

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01755611     History of Changes
Other Study ID Numbers: 116745
Study First Received: December 19, 2012
Last Updated: December 19, 2012
Health Authority: Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Mexico: Ministry of Health

Keywords provided by GlaxoSmithKline:
Minocycline
Mexico
Acne
bioequivalence

Additional relevant MeSH terms:
Acne Vulgaris
Skin Diseases, Infectious
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
 Infection
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013