HealthyPhase 1NCT00836056
Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions
A Phase 1 study testing Clindamycin 300 mg capsule and Cleocin HCl 300 mg capsules in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
Trial summary
The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clindamycin 300 mg capsule and Cleocin HCl 300 mg capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2003to Nov 2003
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Child-bearing potential or non-child-bearing potential female or male, non-smoker, ≥ 18 and ≤65 years of age.
- Non-child-bearing potential female subject is defined as follows:
- Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration.
- Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
- Capable of consent.
Who cannot join
- Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior ot the administration of the study medication.
- Any clinically significant abnormality found during the medical screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive testing for hepatitis B, hepatitis C, or HIV at screening.
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- EGC abnormalities (clinically significant) or vital sign abnormalities(systolic blood pressure lower than 90 over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- BMI≥ 30.0kg/m2.
- History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week ( 1 Unit= 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol) or positive alcohol breath test at screening.
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- History of allergic reactions to clindamycin or other related drugs (e.g. lienomycin).
- History of allergic reactions to heparin.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, haematologic, immunologic, psychiatric, or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products ( including natural food supplements, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Difficulty to swallow study medication.
- Use of any tobacco products in the 90 days preceding drug administration.
- Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Medical Subinvestigator, contraindicate the subjects's participation in this study.
- A depot injection or an implant of any drug within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood prior to administration of the study medication as follows:
- less than 300 mL or whole blood within 30 days,
- 300 mL to 500 mL of whole blood within 45 days,
- more than 500 mL of whole blood within 56 days prior to drug administration.
- Intolerance to venipunctures.
- Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
- Subjects unable to understand or unwilling to sign the Informed Consent Form.
- Clinically significant history of diarrhea subsequent to administration or antibacterial agents or antibiotics.
- Additional exclusion criteria for females only:
- Breast-feeding subject.
- Positive urine pregnancy test at screening
- Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 says prior to study drug administration. Acceptable methods of contraception:
- condom + spermicide,
- diaphragm + spermicide,
- intra-uterine contraceptive devise (placed at least 4 weeks prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Clindamycin 300 mg Capsules and Cleocin HCl Administered as 1 x 300 mg Capsule in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- Clindamycin 300 mg capsule, Cleocin HCl 300 mg capsules
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin 300 mg capsuleDrug
1 x 300 mg
Cleocin HCl 300 mg capsulesDrug
1 x 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin (test) | Experimental | Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period Receives: Drug: Clindamycin 300 mg capsule |
| Cleocin® (reference) | Active comparator | Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period Receives: Drug: Cleocin HCl 300 mg capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence Based on Cmax
Cmax - Maximum Observed Concentration
Measured: Blood samples collected over 24 hour period
Bioequivalence Based on AUCinf
AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Blood samples collected over 24 hour period
Bioequivalence Based on AUC0-t
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
Measured: Blood samples collected over 24 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startNov 2003
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Benoit Girard, M.D., Principal investigator, Anapharn Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836056
- Sponsor's protocol ID
- 30312
- Status last verified
- Aug 2024
- First submitted
- 3 Feb 2009
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-Way Crossover, Bioequivalence Study of Clindamycin 300 mg Capsules and Cleocin HCl Administered as 1 x 300 mg Capsule in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00836056
- Acronym / sponsor ID
- 30312
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 21 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clindamycin (test) | Experimental | Drug: Clindamycin 300 mg capsuleClindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period |
| Cleocin® (reference) | Active comparator | Drug: Cleocin HCl 300 mg capsulesCleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Child-bearing potential or non-child-bearing potential female or male, non-smoker, ≥ 18 and ≤65 years of age.
- Non-child-bearing potential female subject is defined as follows:
- Capable of consent.
Key exclusion criteria (36 listed)
- Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior ot the administration of the study medication.
- Any clinically significant abnormality found during the medical screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
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 |
|---|---|---|
| Clindamycin 300 mg capsule1 x 300 mg | Drug | Clindamycin (test) |
| Cleocin HCl 300 mg capsules1 x 300 mg | Drug | Cleocin® (reference) |
Primary outcome
Bioequivalence Based on Cmax
Time frame: Blood samples collected over 24 hour period
Cmax - Maximum Observed Concentration
Bioequivalence Based on AUCinf
Time frame: Blood samples collected over 24 hour period
AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Bioequivalence Based on AUC0-t
Time frame: Blood samples collected over 24 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Benoit Girard, M.D. principal investigator
Anapharn Inc.
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 Clindamycin 300 mg capsule and Cleocin HCl 300 mg capsules in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
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 5 inclusion and 36 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 19 Aug 2024. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bioequivalence Based on Cmax (time frame: Blood samples collected over 24 hour period). The study lists 3 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 19 Aug 2024.