HealthyPhase 1NCT01888289
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
A Phase 1 study testing Isotretinoin in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Sep 2001
- 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 males between 18 and 45 years of age inclusive.
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).
Who cannot join
- Hypersensitivity to isotretinoin or related compounds.
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- Recent history of mental illness, drug addiction, drug abuse or alcoholism.
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
- Regular tobacco use in the 3 months prior to study dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
AAI
Quadrangle Drive, Chapel Hill,, North Carolina, 27514
About this study
Official title: An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., Under Fasting Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions
Read the detailed description
An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fasting 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 ACCUTANE
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 |
| ACCUTANE | Active comparator | ACCUTANE 40 mg of Roche Laboratories 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, 1,2,3,4,5,6,8,10,16,24,36,48,72 and 96hrs
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 startJul 2001
- Primary completionAug 2001
- Study completionSep 2001
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ralph Scallion, MD, Principal investigator, AAI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888289
- Sponsor's protocol ID
- AAI-US-101
- Status last verified
- Nov 2001
- 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
- An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01888289
- Acronym / sponsor ID
- AAI-US-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Aug 2001 (actual)
- Study completion
- Sep 2001 (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.
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions
Detailed description
An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fasting 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 |
| ACCUTANE | Active comparator | Drug: IsotretinoinACCUTANE 40 mg of Roche Laboratories Inc |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males between 18 and 45 years of age inclusive.
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).
Key exclusion criteria (7 listed)
- Hypersensitivity to isotretinoin or related compounds.
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- Recent history of mental illness, drug addiction, drug abuse or alcoholism.
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
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: ACCUTANEIsotretinoin Capsules,40 mg | Drug | ACCUTANE, Isotretinoin capsules, 40 mg |
Primary outcome
Area under curve (AUC)
Time frame: Pre-dose (0) and 0.5, 1,2,3,4,5,6,8,10,16,24,36,48,72 and 96hrs
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. Ralph Scallion, MD principal investigator
AAI
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 United States.
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 3 inclusion and 7 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 United States. 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, 1,2,3,4,5,6,8,10,16,24,36,48,72 and 96hrs). 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.