FastingMinocyclineNCT01067001
Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study
An observational study of Fasting, run by Amneal Pharmaceuticals Co. India Private Limited at 1 site in India.
Trial summary
To determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135 mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt. Ltd., India and SOLODYN® (minocycline hydrochloride) Extended Release Tablets 135 mg Manufactured for Medicis, The Dermatology Company, Scottsdale, AZ 85256, by Wellspring… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- How many people
- 18 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2009to Nov 2009
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 18 normal, healthy, adult, human subjects will be enrolled in the study.
Who may be able to join
- Healthy human subjects aged between 18 and 45 years.(including both) Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) and body weight not less than 45 Kgs.
- Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests Subjects having normal 12-lead electrocardiogram (ECG). Subjects having normal chest X-Ray (P/A view). Subjects able to communicate effectively. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- Female subjects who are postmenopausal or surgically sterile. Female subjects practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
Who cannot join
- Subjects having contraindications or hypersensitivity to minocycline or related group of drugs.
- History or presence of any medical condition or disease according to the opinion of the physician.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
- Difficulty with donating blood.
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- Difficulty in swallowing solids like tablets or capsules.
- Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
- Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- Pulse rate less than 50 beats/minute or more than 100 beats/minute.
- Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing.
- Major illness during 3 months before screening.
- Participation in a drug research study within past 3 months.
- Donation of blood in the past 3 months before screening.
- Female subjects demonstrating a positive pregnancy screen.
- Female subjects who are currently breast-feeding.
- Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover, Bioequivalence Study in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.
To determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135 mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt. Ltd., India and SOLODYN® (minocycline hydrochloride) Extended Release Tablets 135 mg Manufactured for Medicis, The Dermatology Company, Scottsdale, AZ 85256, by Wellspring Pharmaceutical Canada Corp., Oakville, Ontario L6H 1M5 in normal, healthy, adult, human subjects under fasting condition.
Read the detailed description
Subjects will be fasted for at least 10 hours prior to scheduled time for dosing. As per the randomization schedule, one tablet of test or reference product will be administered to each subject with 240 mL of water at ambient temperature in each period.
Twenty four samples will be collected from each subject during each period. The venous blood samples (5 mL each) will be withdrawn at pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 2.50, 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00, 96.00, and 120.00 hours after dosing. The samples collected at 48.00, 72.00, 96.00, and 120.00 hours after dosing will be on an ambulatory basis (i.e. on separate visit).
After collecting the blood samples from all the subjects at each sampling time point, samples will be centrifuged under refrigeration with machine set at 3000 rpm, 10 minutes and 4oC. After centrifugation, the plasma samples will be separated and transferred into respective prelabeled polypropylene tubes. These polypropylene tubes will be stored below -20°C for a maximum period of 12 hours and then they will be stored at -70°C ± 20°C until withdrawn for analysis.
Samples from all the subjects completing both periods of the study as per the approved protocol will be analyzed.
- Conditions
- Fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 Way Crossover | 2 Way Crossover bioequivalence study | |
| Subjects will be randomly divided in to 2 groups. | A total of 18 normal, healthy, adult, human subjects will be enrolled in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following parameters will be considered as primary end points to determine the bioequivalence of test and reference products: Cmax, AUC0-t and AUC0-INF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- Observational
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals Co. India Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Nikunj Patel, MD, Pharmacology, Study director, Director, CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067001
- Sponsor's protocol ID
- Amneal-10-01
- Acronym
- Minocycline
- Status last verified
- Feb 2010
- First submitted
- 9 Feb 2010
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover, Bioequivalence Study in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT01067001
- Acronym / sponsor ID
- Minocycline / Amneal-10-01
- Conditions
- Fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals Co. India Private LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 11 Feb 2010 (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 determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135 mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt. Ltd., India and SOLODYN® (minocycline hydrochloride) Extended Release Tablets 135 mg Manufactured for Medicis, The Dermatology Company, Scottsdale, AZ 85256, by Wellspring Pharmaceutical Canada Corp., Oakville, Ontario L6H 1M5 in normal, healthy, adult, human subjects under fasting condition.
Detailed description
Subjects will be fasted for at least 10 hours prior to scheduled time for dosing. As per the randomization schedule, one tablet of test or reference product will be administered to each subject with 240 mL of water at ambient temperature in each period.
Twenty four samples will be collected from each subject during each period. The venous blood samples (5 mL each) will be withdrawn at pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 2.50, 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00, 96.00, and 120.00 hours after dosing. The samples collected at 48.00, 72.00, 96.00, and 120.00 hours after dosing will be on an ambulatory basis (i.e. on separate visit).
After collecting the blood samples from all the subjects at each sampling time point, samples will be centrifuged under refrigeration with machine set at 3000 rpm, 10 minutes and 4oC. After centrifugation, the plasma samples will be separated and transferred into respective prelabeled polypropylene tubes. These polypropylene tubes will be stored below -20°C for a maximum period of 12 hours and then they will be stored at -70°C ± 20°C until withdrawn for analysis.
Samples from all the subjects completing both periods of the study as per the approved protocol will be analyzed.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 Way Crossover | – | –2 Way Crossover bioequivalence study |
| Subjects will be randomly divided in to 2 groups. | – | –A total of 18 normal, healthy, adult, human subjects will be enrolled in the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 18 normal, healthy, adult, human subjects will be enrolled in the study.
Key inclusion criteria (3 listed)
- Healthy human subjects aged between 18 and 45 years.(including both) Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) and body weight not less than 45 Kgs.
- Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests Subjects having normal 12-lead electrocardiogram (ECG). Subjects having normal chest X-Ray (P/A view). Subjects able to communicate effectively. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- Female subjects who are postmenopausal or surgically sterile. Female subjects practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
Key exclusion criteria (17 listed)
- Subjects having contraindications or hypersensitivity to minocycline or related group of drugs.
- History or presence of any medical condition or disease according to the opinion of the physician.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The following parameters will be considered as primary end points to determine the bioequivalence of test and reference products: Cmax, AUC0-t and 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 11 Feb 2010.
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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. Nikunj Patel, MD, Pharmacology study director
Director, CRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting, run by Amneal Pharmaceuticals Co. India Private 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 3 inclusion and 17 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 11 Feb 2010. 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.
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?
The following parameters will be considered as primary end points to determine the bioequivalence of test and reference products: Cmax, AUC0-t and AUC0-INF. 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 11 Feb 2010.