HealthyPhase 1NCT01888224
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
A Phase 1 study testing Isotretinoin in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin) Capsules 40 mg after single oral dose administration to healthy, normal, adult, human male subjects under fed condition. 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
- Healthy
- What is being tested?
- Isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2011to Jul 2011
- 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
- Healthy adult human male volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having a Body Mass Index (BMI) between 18.5-27.5 (both inclusive), calculated as weight in kg / height in meter2.
- Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination,laboratory evaluations, 12- lead ECG and X-ray chest recordings.
- Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- Able to comply to use 2 forms of effective contraception methods simultaneously during Isotretinoin study, and for 1 month after study.
- Able to give voluntary written informed consent for participation in the trial.
- Able to read and/or understand drug medication Guide either in English or in a provided translation when given along with informed consent form.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to Isotretinoin or any of the excipients including parabens or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of any medicine including herbal medicines at any time within 14 days before dosing in Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- Use of any recreational drugs or history of drug addiction or testing positive in prestudy drug scans.
- A recent history of harmful use of alcohol(less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum,whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine.
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- Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain from smoking during the study.
- The presence of clinically significant abnormal laboratory values during screening.
- History or presence of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With Amnesteem Capsules 40 mg of Mylan Pharmaceuticals Inc., in Healthy, Adult, Male Human Subjects Under Fed Conditions.
To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin) Capsules 40 mg after single oral dose administration to healthy, normal, adult, human male subjects under fed condition.
Read the detailed description
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Isotretinoin Capsules 40 mg under fed conditions.
- Conditions
- Healthy
- Being tested
- Isotretinoin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Also called AMNESTEEM
Isotretinoin Capsules,40 mg
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin capsules, 40 mg | Experimental | Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd Receives: Drug: Isotretinoin |
| AMNESTEEM | Active comparator | AMNESTEEM 40 mg of Mylan Pharmaceuticals Inc Receives: Drug: Isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC)
Measured: Pre-dose (0) and 0.5, 1,1.5,2,2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8,10,12,16,20,24, 36, 48,72 and 96 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Alpeshkumar Patel, MD, Principal investigator, Lambda Therapeutic Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888224
- Sponsor's protocol ID
- 618-10
- Status last verified
- Aug 2011
- First submitted
- 25 Jun 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With Amnesteem Capsules 40 mg of Mylan Pharmaceuticals Inc., in Healthy, Adult, Male Human Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT01888224
- Acronym / sponsor ID
- 618-10
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Jun 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.
To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin) Capsules 40 mg after single oral dose administration to healthy, normal, adult, human male subjects under fed condition.
Detailed description
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Isotretinoin Capsules 40 mg under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin capsules, 40 mg | Experimental | Drug: IsotretinoinIsotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd |
| AMNESTEEM | Active comparator | Drug: IsotretinoinAMNESTEEM 40 mg of Mylan Pharmaceuticals Inc |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult human male volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having a Body Mass Index (BMI) between 18.5-27.5 (both inclusive), calculated as weight in kg / height in meter2.
- Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination,laboratory evaluations, 12- lead ECG and X-ray chest recordings.
- Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- Able to comply to use 2 forms of effective contraception methods simultaneously during Isotretinoin study, and for 1 month after study.
Key exclusion criteria (11 listed)
- Known hypersensitivity or idiosyncratic reaction to Isotretinoin or any of the excipients including parabens or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of any medicine including herbal medicines at any time within 14 days before dosing in Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- Use of any recreational drugs or history of drug addiction or testing positive in prestudy drug scans.
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 |
|---|---|---|
| IsotretinoinAlso: AMNESTEEMIsotretinoin Capsules,40 mg | Drug | AMNESTEEM, Isotretinoin capsules, 40 mg |
Primary outcome
Area under curve (AUC)
Time frame: Pre-dose (0) and 0.5, 1,1.5,2,2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8,10,12,16,20,24, 36, 48,72 and 96 hrs
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 27 Jun 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.
Dr. Alpeshkumar Patel, MD principal investigator
Lambda Therapeutic Research Limited
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 in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 7 inclusion and 11 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 27 Jun 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 India. 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 curve (AUC) (time frame: Pre-dose (0) and 0.5, 1,1.5,2,2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8,10,12,16,20,24, 36, 48,72 and 96 hrs). 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 27 Jun 2013.