Healthy VolunteersNCT01080586
Bioequivalence Study of Cyclosporine 100mg Capsule Under Fed Condition
A study testing Cyclosporine Capsules USP (Modified) 100 mg in people with Healthy Volunteers, run by Panacea Biotec Ltd at 1 site in India.
Trial summary
To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis Pharmaceuticals Corporation, New Jersey, in 78… 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 Volunteers
- What is being tested?
- Cyclosporine Capsules USP (Modified) 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2007to Oct 2007
- 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
- Male subjects in the range of 18 - 45 years of age.
- The healthy human subjects, whose body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart (Appendix A).
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate and body temperature).
- Subjects with normal findings as determined by hematological tests, Serum Chemistry, serological tests, urine analysis, ECG and X-ray (X-ray if taken).
- Willingness to follow the protocol requirement as evidenced by written, informed consent.
- Agreeing to, not using any medication (either prescribed, OTC or alternate medicines), including vitamins and minerals for 14 days prior to study and during the course of the study.
- No history or presence of significant alcoholism or drug abuse in the past one year.
- Non-smokers, ex smokers and light smokers will be included. "Light smokers are defined as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely stopped smoking for at least 3 months.
Who cannot join
- Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day one (1).
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic or psychiatric diseases.
- Subjects with history of recent myocardial infarction, cardiac arrhythmias, cardiac failure and convulsions.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
- History of malignancy or other serious diseases.
Show all 17Show fewer
- Refusal to abstain from food for at least ten (10.00) hours prior to drug administration and for at least four (04.00) hours post dose.
- Refusal to abstain from water for at least one (01.00) hour prior to study drug administration on first day of each study period and for at least two (02.00) hours post dose.
- Any contraindication with blood sampling.
- Refusal to abstain from smoking or consumption of tobacco products 48.00 hours before dosing until last sample collection of each period.
- Found positive in Breath alcohol test done at the time of check in for each study period.
- History of drug abuse in the past one year.
- Use of xanthine-containing beverages or food, and grape fruit juice for 48.00 hours prior to each drug dose.
- Blood donation 90 days prior to the commencement of the study.
- Subjects with positive HBsAg or Hepatitis-C tests or HIV tests or Anti Treponema Palladium/Syphilis test.
- Known history of hypersensitivity to Cyclosporine or to any component of the formulation.
- -
Trial locations and contacts
1 site in 1 country.
India1 site
Accutest Research Laboratories (I) Pvt Ltd.
Ahmedabad, Gujarat, 380015
About this study
Official title: A Randomized Single Dose Open Label Bioequivalence Study of Cyclosporine Capsules USP (Modified)100mg in Normal Healthy Male Subjects Under Fed Condition
To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis Pharmaceuticals Corporation, New Jersey, in 78 healthy adult male subjects under fed condition.
Read the detailed description
Total 78 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to High Fat Breakfast half an hour before administration of the study drug and for four (4) additional hours each, post dose during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period. A total of 24 blood samples will be withdrawn for pharmacokinetic profiling. The whole blood concentrations of Cyclosporine will be measured by a validated LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
- Conditions
- Healthy Volunteers
- Being tested
- Cyclosporine Capsules USP (Modified) 100 mg
- Keywords
- Bioequivalence study in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine Capsules USP (Modified) 100 mgDrug
Also called Cyclosporine Capsule, Gengraf Capsule, Sandimmune Capsule
Subjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule
| Study group | Role | What they receive |
|---|---|---|
| NEORAL® Capsule 100 mg | Active comparator | Not described Receives: Drug: Cyclosporine Capsules USP (Modified) 100 mg |
| Cyclosporine 100 mg Capsule | Experimental | Not described Receives: Drug: Cyclosporine Capsules USP (Modified) 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate bioequivalence between Test Product,Cyclosporine Soft Gelatin Capsules Modified 100mg of Panacea Biotec and the corresponding Reference Product, Neoral(Cyclosporine Capsule,USP)of Novartis Pharmaceutical Corporation, New Jersey
Measured: upto 3 days
Secondary outcomes (1)
To monitor the safety and tolerability of single dose of cyclosporine in subjects
Measured: upto 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startSep 2007
- Primary completionSep 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panacea Biotec Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Nirav Gandhi, Principal investigator, Accutest Research Laboratories (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080586
- Sponsor's protocol ID
- US/AHD/07/014
- Status last verified
- Mar 2010
- First submitted
- 2 Mar 2010
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Dose Open Label Bioequivalence Study of Cyclosporine Capsules USP (Modified)100mg in Normal Healthy Male Subjects Under Fed Condition
- ClinicalTrials.gov ID
- NCT01080586
- Acronym / sponsor ID
- US/AHD/07/014
- Conditions
- Healthy Volunteers
- Keywords
- Bioequivalence study in healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Panacea Biotec LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 4 Mar 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 demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis Pharmaceuticals Corporation, New Jersey, in 78 healthy adult male subjects under fed condition.
Detailed description
Total 78 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to High Fat Breakfast half an hour before administration of the study drug and for four (4) additional hours each, post dose during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post dose in each period. A total of 24 blood samples will be withdrawn for pharmacokinetic profiling. The whole blood concentrations of Cyclosporine will be measured by a validated LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEORAL® Capsule 100 mg | Active comparator | Drug: Cyclosporine Capsules USP (Modified) 100 mg |
| Cyclosporine 100 mg Capsule | Experimental | Drug: Cyclosporine Capsules USP (Modified) 100 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male subjects in the range of 18 - 45 years of age.
- The healthy human subjects, whose body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart (Appendix A).
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate and body temperature).
- Subjects with normal findings as determined by hematological tests, Serum Chemistry, serological tests, urine analysis, ECG and X-ray (X-ray if taken).
- Willingness to follow the protocol requirement as evidenced by written, informed consent.
Key exclusion criteria (17 listed)
- Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day one (1).
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic or psychiatric diseases.
- Subjects with history of recent myocardial infarction, cardiac arrhythmias, cardiac failure and convulsions.
- Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
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 |
|---|---|---|
| Cyclosporine Capsules USP (Modified) 100 mgAlso: Cyclosporine Capsule, Gengraf Capsule, Sandimmune CapsuleSubjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule | Drug | Cyclosporine 100 mg Capsule, NEORAL® Capsule 100 mg |
Primary outcome
To demonstrate bioequivalence between Test Product,Cyclosporine Soft Gelatin Capsules Modified 100mg of Panacea Biotec and the corresponding Reference Product, Neoral(Cyclosporine Capsule,USP)of Novartis Pharmaceutical Corporation, New Jersey
Time frame: upto 3 days
1 secondary outcome
To monitor the safety and tolerability of single dose of cyclosporine in subjects
Time frame: upto 3 months
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 4 Mar 2010.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 Nirav Gandhi principal investigator
Accutest Research Laboratories (I) Pvt. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclosporine Capsules USP (Modified) 100 mg in people with Healthy Volunteers, run by Panacea Biotec Ltd 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 8 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 4 Mar 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?
To demonstrate bioequivalence between Test Product,Cyclosporine Soft Gelatin Capsules Modified 100mg of Panacea Biotec and the corresponding Reference Product, Neoral(Cyclosporine Capsule,USP)of Novartis Pharmaceutical Corporation, New Jersey (time frame: upto 3 days). 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 4 Mar 2010.