Skin DiseasesPhase 1NCT01938508
Minocycline Bioequivalence Study
A Phase 1 study testing Minocycline in people with Skin Diseases, run by GlaxoSmithKline at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- May 2013to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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).
- Prior to joining the first period sign a commitment letter no pregnancy.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study Between Two Medications for the Oral Administration of 100 mg of Minocycline in Oral Solids in Healthy Volunteers.
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
- Being tested
- Minocycline
- Keywords
- dermatitis, Minocycline, bioavailability
- Medical subject headings
- Skin Diseases, Dermatitis, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Minocycline 100 mg capsules Darier SA Dermatological Laboratories de CV (Micromycin ®). Receives: Drug: Minocycline |
| Reference | Experimental | Minocycline 100 mg capsules (Micocin ®) Marketed and distributed by Triax Pharmaceuticals Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CECYC (Center of Scientific and Clinical Studies, CRO)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938508
- Sponsor's protocol ID
- 200611
- Status last verified
- Nov 2013
- First submitted
- 5 Sep 2013
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study Between Two Medications for the Oral Administration of 100 mg of Minocycline in Oral Solids in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01938508
- Acronym / sponsor ID
- 200611
- Conditions
- Skin Diseases
- Keywords
- dermatitis, Minocycline, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- CECYC (Center of Scientific and Clinical Studies, CRO)
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: MinocyclineMinocycline 100 mg capsules Darier SA Dermatological Laboratories de CV (Micromycin ®). |
| Reference | Experimental | Drug: MinocyclineMinocycline 100 mg capsules (Micocin ®) Marketed and distributed by Triax Pharmaceuticals |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocyclineminocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline | Drug | Reference, Test |
Primary outcome
Bioavailability as assessed by composite of PK parameters.
Time frame: 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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minocycline in people with Skin Diseases, run by GlaxoSmithKline at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability as assessed by composite of PK parameters. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2013.