Acne VulgarisPhase 1NCT02498288
A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition
A Phase 1 study testing Isotretinoin: Reference Medication 1, Isotretinoin: Reference Medication 2 and Isotretinoin: Test Medication in people with Acne Vulgaris, run by GlaxoSmithKline at 1 site in Mexico.
Trial summary
This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Isotretinoin: Reference Medication 1, Isotretinoin: Reference Medication 2 and Isotretinoin: Test Medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 31 May 2013to 15 Jul 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Included in study will be male volunteers.
- Ages between 18 and 45 years old.
- BMI (Body Mass Index) between 20 to 26 kilogram/meter square (kg/m^2).
- Anti-doping tests negative results.
- Negative test results for Ac human immunodeficiency virus (HIV), HBsAg (hepatitis B surface antigen), and rapid plasma regain (RPR; syphilis test).
- Clinical biochemical test values: Hematic Biometry, Urine Analysis, Biochemical Profile: (Glucose, Ureic Nitrogen, Urea, Creatinine, Uric Acid, Cholesterol, Triglycerides, Total Proteins, Albumin, Globulin, Bilirubin (total, indirect and direct), Alkaline Phosphatase (ALP), Lactic Dehydrogenase, Asparate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), Ac HIV, HBsAg and RPR, must fall within an interval between minimum and maximum values in connection to said tests accepted values.
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- Normal Electrocardiogram (ECG) and Chest X-rays.
- Complete the scale 'Columbia Suicide Severity Rating Scale' (C-SSRS), before and after each dosification period.
- Obtain a grade of zero in the C-SSRS.
- Signed the Informed Consent corresponding to the bioequivalence study.
- In exception cases, accepted may be a candidate for which any previously mentioned test is exceeded regarding considered valid maximum and minimum accepted normal values, as long as it involves an isolated value and there are no other manifestations which could allow assuming that a given value is related to a disease or is remnant of another. These cases must be approved by clinical area and declared as "Non-clinically significant".
Who cannot join
- Electrocardiographic Anomalies; radiological
- Anti-doping tests positive results,
- Positive results regarding RPR; HIV and HBsAg tests.
- Personal or family history of allergy to medication in question.
- Having any kind of allergy, since these persons are in higher risk of suffering from medication allergy.
- Tobacco use.
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- Persons undergoing any medical treatment.
- Existence of concurrent or intercurrent disease.
- History psychiatric disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia).
- Existence of justified doubt regarding questionnaire answers truthfulness.
- Having participated in bioequivalence or bioavailability studies or having donated blood 2 months before the study.
- Presence of clinically important gastrointestinal diseases or malabsorption history during the last year.
- Presence of a medical condition requiring regular medication (with prescription or over-the- counter medication) with systemic absorption.
- Drugs or alcohol addiction history requiring treatment.
- Refuse to take the scale 'C-SSRS, before and after each dosification period.
- Obtain a grade greater than zero in the C-SSRS.
- Do not sign the Informed Consent corresponding to the bioequivalence study.
- Finally, excluded will be all those volunteers not meeting that established in Mexican Official Standard NOM-177-SSA1-1998.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study for an Isotretinoin Pharmaceutical Preparation - Capsules. Open, Crossover, Randomized, Single Dose, Three Treatments, Three Periods and Six Sequences With Meal (Breakfast) Study
This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin. Bioequivalence will be compared between the reference medication one (T1) vs the test medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3): (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they are bioequivalent.
- Conditions
- Acne Vulgaris
- Being tested
- Isotretinoin: Reference Medication 1, Isotretinoin: Reference Medication 2, Isotretinoin: Test Medication
- Keywords
- capsule, Isotretinoin, Bioequivalence
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotretinoin: Reference Medication 1Drug
Isotretinoin reference medication 1 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each)
Isotretinoin: Reference Medication 2Drug
Isotretinoin reference medication 2 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each)
Isotretinoin: Test MedicationDrug
Isotretinoin test medication will contain isotretinoin 40 mg (2 capsules of 20 mg each) in the same type of pharmaceutical presentation, containing the same drug but possible to have a different excipients.
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin Arm | Experimental | All subjects in this study will be randomized to receive all the 3 distinct medications of isotretinoin in a sequential manner. Subjects will receive a single dosage of two capsules x 20 mg (40 mg) orally, for three periods, six sequences, with a wash-out period of two weeks to eliminate the first dosage. Receives: Drug: Isotretinoin: Reference Medication 1; Drug: Isotretinoin: Reference Medication 2; Drug: Isotretinoin: Test Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from zero hours to last quantifiable time (AUC0-t)
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Measured: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Area under the plasma concentration-time curve from zero hours to infinite (AUC0-infinity)
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Measured: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Maximum drug concentration (Cmax)
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Measured: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Time to maximum drug concentration (Tmax)
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Measured: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study start31 May 2013
- Primary completion15 Jul 2013
- Study completion15 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498288
- Sponsor's protocol ID
- 200115
- Status last verified
- Jun 2017
- First submitted
- 16 May 2013
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study for an Isotretinoin Pharmaceutical Preparation - Capsules. Open, Crossover, Randomized, Single Dose, Three Treatments, Three Periods and Six Sequences With Meal (Breakfast) Study
- ClinicalTrials.gov ID
- NCT02498288
- Acronym / sponsor ID
- 200115
- Conditions
- Acne Vulgaris
- Keywords
- capsule, Isotretinoin, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 May 2013 (actual)
- Primary completion
- 15 Jul 2013 (actual)
- Study completion
- 15 Jul 2013 (actual)
- First posted
- 15 Jul 2015 (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 is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin. Bioequivalence will be compared between the reference medication one (T1) vs the test medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3): (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they are bioequivalent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin Arm | Experimental | Drug: Isotretinoin: Reference Medication 1, Drug: Isotretinoin: Reference Medication 2, Drug: Isotretinoin: Test MedicationAll subjects in this study will be randomized to receive all the 3 distinct medications of isotretinoin in a sequential manner. Subjects will receive a single dosage of two capsules x 20 mg (40 mg) orally, for three periods, six sequences, with a wash-out period of two weeks to eliminate the first dosage. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Included in study will be male volunteers.
- Ages between 18 and 45 years old.
- BMI (Body Mass Index) between 20 to 26 kilogram/meter square (kg/m^2).
- Anti-doping tests negative results.
- Negative test results for Ac human immunodeficiency virus (HIV), HBsAg (hepatitis B surface antigen), and rapid plasma regain (RPR; syphilis test).
Key exclusion criteria (18 listed)
- Electrocardiographic Anomalies; radiological
- Anti-doping tests positive results,
- Positive results regarding RPR; HIV and HBsAg tests.
- Personal or family history of allergy to medication in question.
- Having any kind of allergy, since these persons are in higher risk of suffering from medication allergy.
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 |
|---|---|---|
| Isotretinoin: Reference Medication 1Isotretinoin reference medication 1 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each) | Drug | Isotretinoin Arm |
| Isotretinoin: Reference Medication 2Isotretinoin reference medication 2 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each) | Drug | Isotretinoin Arm |
| Isotretinoin: Test MedicationIsotretinoin test medication will contain isotretinoin 40 mg (2 capsules of 20 mg each) in the same type of pharmaceutical presentation, containing the same drug but possible to have a different excipients. | Drug | Isotretinoin Arm |
Primary outcome
Area under the plasma concentration-time curve from zero hours to last quantifiable time (AUC0-t)
Time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Area under the plasma concentration-time curve from zero hours to infinite (AUC0-infinity)
Time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Maximum drug concentration (Cmax)
Time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
Time to maximum drug concentration (Tmax)
Time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period
Bioequivalence will be evaluated for isotretinoin 40 mg using three distinct medications; two assigned as reference medication (T1 and T2) and 1 test medication (T3). Each subject will receive 2 capsules (20 mg each) orally.
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 12 Jun 2017.
- Results for study 200115 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 Isotretinoin: Reference Medication 1, Isotretinoin: Reference Medication 2 and Isotretinoin: Test Medication in people with Acne Vulgaris, 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 11 inclusion and 18 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 12 Jun 2017. 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?
Area under the plasma concentration-time curve from zero hours to last quantifiable time (AUC0-t) (time frame: Pre-dose and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours post dose in each treatment period). The study lists 4 primary outcomes in all. 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 12 Jun 2017.