NCT01938508

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

May 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
Last Updated

November 18, 2013

Status Verified

November 1, 2013

Enrollment Period

1 month

First QC Date

September 5, 2013

Last Update Submit

November 14, 2013

Conditions

Skin Diseases

Keywords

dermatitisMinocyclinebioavailability

Outcome Measures

Primary Outcomes (1)

  • Bioavailability as assessed by composite of PK parameters.

    The following pharmacokinetic (PK) parameters will assessed maximum observed concentration (Cmax), Area under the concentration time curve from time zero (pre-dose) to last common time of quantifiable concentration within a subject across all treatments (AUC0-t) and Area under the concentration time curve from time zero (pre-dose) extrapolated to infinite time (AUC0-inf).

    The samples were collected for each period to 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, 36.0, 48.0 and 72.0 hours after administration

Study Arms (2)

Test

EXPERIMENTAL

Minocycline 100 mg capsules Darier SA Dermatological Laboratories de CV (Micromycin ®).

Drug: Minocycline

Reference

EXPERIMENTAL

Minocycline 100 mg capsules (Micocin ®) Marketed and distributed by Triax Pharmaceuticals

Drug: Minocycline

Interventions

MinocyclineDRUG

minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline

ReferenceTest

Eligibility Criteria

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

You may qualify if:

  • Subjects aged between 18 and 55 years, of both genders.
  • Subjects who are in good health, based on the results of a complete medical history, valid for 6 months prior to baseline.
  • Subjects with laboratory studies, liver transaminases, hepatitis B test and C, HIV and Venereal Disease Research Laboratory (VDRL). These laboratory studies have been issued within 6 months prior to the start of this study.
  • Subjects who have 12-lead ECG no more than six months prior to baseline and this should be normal or normal physiologic variants.
  • Subjects that have a normal chest radiograph or physiologically normal anatomic variants.
  • Subjects with negative result in urine drug tests.
  • Subjects with negative test alcoholometry.
  • Female subjects with urine pregnancy test negative.
  • Subjects with a Body Mass Index (BMI) ranging from 19 to 26.5 kg/m2.
  • Subjects with laboratory results within the reference values or to +/- 10%. And if you have isolated abnormality above 10% is considered low clinical relevance criterion of Principal Investigator and indicate the relevance or otherwise of voluntary participation, as long as they ensure the safety of volunteers.
  • Subjects with vital signs diastolic pressure between 50 and 89 mmHg and between 90 and 139 mmHg for systolic, pulse rate between 55 and 100 beats per minute, respiratory rate of 12-24 breaths per minute and a temperature of 35.0 to 37.5 ° C.
  • Nonsmokers or smokers who have not smoked at least 10 hours before the start of the study.
  • Without alcohol intake for 48 hours prior to study drug administration.
  • Subjects signed informed consent, having informed the potential risks and benefits of participation, and their willingness and availability to participate in the full study, may leave the study at the time they so choose.
  • Female participants must not be pregnant or breast-feeding, plus those who are sexually active should have a method of birth control to prevent pregnancy during the investigation considered the following secure methods (Male condom combined with a vaginal spermicide (Foam, gel, film, cream, or suppository, combined with a male condom female diaphragm, either with or without a vaginal spermicide, intrauterine device and also provide you with a list of other contraceptive methods in order that you do not become pregnant during the investigation).
  • +1 more criteria

You may not qualify if:

  • Subjects with a history of hypersensitivity to the study drug or any other drugs belonging to the group of study drug.
  • Subjects with a history of cardiovascular disease, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic, psychiatric or other organic abnormalities.
  • Subjects requiring any other medications that interfere with the quantification and / or kinetic study drug.
  • Subjects exposed to agents known as inducers or inhibitors of hepatic enzyme systems.
  • Subjects who had taken potentially toxic drugs within 30 days before the start of the study.
  • Subjects who have taken any drug within 14 days or 7 half-lives before the start of the study.
  • Subjects who were hospitalized for any reason or were seriously ill within 60 days before the study.
  • Subjects who have received an investigational drug within 60 days before the start of the study.
  • Subjects who have donated or lost 450 mL or more of blood within 45 days prior to baseline.
  • Subjects with a recent history of drug abuse, including alcohol.
  • Female subjects with a positive pregnancy test in urine.
  • Subjects who consumed food or beverages that interact pharmacologically with the study drug (particularly those that are known sources of xanthines: caffeine, cola drinks, theobromine, and theophylline in the 10 hours before the test.
  • Subjects with grapefruit juice consumption in the 10 hours before the test.
  • Subjects with inability to understand or unwilling to sign the consent form.
  • Subjects who are discharged from the database by COFEPRIS are participating in another study of bioequivalence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Mexico City, 03100, Mexico

Location

MeSH Terms

Conditions

Skin DiseasesDermatitiscyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Skin and Connective Tissue 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
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 18, 2013

Record last verified: 2013-11

Locations

ME(1)