HealthyNCT00775255
Bioequivalence Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fasting Conditions
A study testing clarithromycin 250 mg/5 mL powder for oral suspension in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
Trial summary
To compare the single-dose oral bioavailability of clarithromycin 250-mg/5 mL powder for oral suspension of Ranbaxy Laboratories with that of Abbott Laboratories (Biaxin®) following administration of a 250 mg/5 mL dose in healthy, adult, human, male subjects 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?
- clarithromycin 250 mg/5 mL powder for oral suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2005to Dec 2005
- Phase
- Interventional
- 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
- Be in the age range of 18-45 years.
- Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Have voluntarily given written informed consent to participate in this study.
- Be of normal health as determined by medical history and physical examination of the subjects performed within 14 days prior to the commencement of the study.
Who cannot join
- History of allergy to clarithromycin, erythromycin and related macrolides.
- History of severe diarrhoea within 2 weeks preceding Day 1 of this study.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which were significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
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- Presence of values which were significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
- Clinically abnormal ECG or Chest X-ray.
- QTc interval beyond normal limits.
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
- History of any psychiatric illness which might have impair the ability to provide written informed consent.
- Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
- Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover, Bioavailability Study on Clarithromycin Formulations Comparing Clarithromycin 250 mg/5 mL Powder for Oral Suspension of Ranbaxy Laboratories With Biaxin® Granules 250 mg/5 mL Oral Suspension in Healthy, Adult, Human, Male Subjects Under Fasting Conditions.
To compare the single-dose oral bioavailability of clarithromycin 250-mg/5 mL powder for oral suspension of Ranbaxy Laboratories with that of Abbott Laboratories (Biaxin®) following administration of a 250 mg/5 mL dose in healthy, adult, human, male subjects under fasting conditions.
Read the detailed description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study on clarithromycin formulations comparing clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin® granules 250 mg/5 mL oral suspension (containing clarithromycin 250 mg/5mL) of Abbott Laboratories in healthy, adult, human, male subjects under fasting conditions.
A single oral dose of clarithromycin 250-mg/5 mL was administered during each period of the study under supervision of a trained Medical Officer.
During the course of the study safety parameters assessed were vital signs, twelve-lead ECG, clinical examination, medical history, clinical laboratory safety tests (hematology, biochemical parameters and urine analysis) at base line and hematology and biochemical parameters at 24 hours post dose of the last period of the study. Twelve-lead ECG was recorded at 4 and 8 hours post-dose in each period.
A Validated analytical method was used for the analysis of Clarithromycin in human plasma. Pharmacokinetic and statistical analysis was performed to conclude the bioequivalence.
- Conditions
- Healthy
- Being tested
- clarithromycin 250 mg/5 mL powder for oral suspension
- Keywords
- Bioequiavelnce clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin 250 mg/5 mL powder for oral suspensionDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories Receives: Drug: clarithromycin 250 mg/5 mL powder for oral suspension |
| 2 | Active comparator | Biaxin® granules 250 mg/5 mL oral suspension Receives: Drug: clarithromycin 250 mg/5 mL powder for oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startSep 2005
- Primary completionSep 2005
- Study completionDec 2005
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775255
- Sponsor's protocol ID
- CPU-M-025/CLARI-250/05
- Status last verified
- Oct 2008
- First submitted
- 16 Oct 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover, Bioavailability Study on Clarithromycin Formulations Comparing Clarithromycin 250 mg/5 mL Powder for Oral Suspension of Ranbaxy Laboratories With Biaxin® Granules 250 mg/5 mL Oral Suspension in Healthy, Adult, Human, Male Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00775255
- Acronym / sponsor ID
- CPU-M-025/CLARI-250/05
- Conditions
- Healthy
- Keywords
- Bioequiavelnce clarithromycin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Oct 2008 (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 compare the single-dose oral bioavailability of clarithromycin 250-mg/5 mL powder for oral suspension of Ranbaxy Laboratories with that of Abbott Laboratories (Biaxin®) following administration of a 250 mg/5 mL dose in healthy, adult, human, male subjects under fasting conditions.
Detailed description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study on clarithromycin formulations comparing clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin® granules 250 mg/5 mL oral suspension (containing clarithromycin 250 mg/5mL) of Abbott Laboratories in healthy, adult, human, male subjects under fasting conditions.
A single oral dose of clarithromycin 250-mg/5 mL was administered during each period of the study under supervision of a trained Medical Officer.
During the course of the study safety parameters assessed were vital signs, twelve-lead ECG, clinical examination, medical history, clinical laboratory safety tests (hematology, biochemical parameters and urine analysis) at base line and hematology and biochemical parameters at 24 hours post dose of the last period of the study. Twelve-lead ECG was recorded at 4 and 8 hours post-dose in each period.
A Validated analytical method was used for the analysis of Clarithromycin in human plasma. Pharmacokinetic and statistical analysis was performed to conclude the bioequivalence.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clarithromycin 250 mg/5 mL powder for oral suspensionclarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories |
| 2 | Active comparator | Drug: clarithromycin 250 mg/5 mL powder for oral suspensionBiaxin® granules 250 mg/5 mL oral suspension |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be in the age range of 18-45 years.
- Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Have voluntarily given written informed consent to participate in this study.
- Be of normal health as determined by medical history and physical examination of the subjects performed within 14 days prior to the commencement of the study.
Key exclusion criteria (17 listed)
- History of allergy to clarithromycin, erythromycin and related macrolides.
- History of severe diarrhoea within 2 weeks preceding Day 1 of this study.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which were significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
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 |
|---|---|---|
| clarithromycin 250 mg/5 mL powder for oral suspension | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 20 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clarithromycin 250 mg/5 mL powder for oral suspension in people with Healthy, run by Ranbaxy 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 4 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 20 Oct 2008. 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?
Bioequivalence. 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 20 Oct 2008.