Fasting StatePhase 1NCT01577914
Bioequivalence Study of Carvedilol Tablets USP 12.5 mg Under Fasting Condition
A Phase 1 study testing Carvedilol Tablets USP 12.5 mg and Carvedilol in people with Fasting State, run by IPCA Laboratories Ltd. at 1 site in India.
Trial summary
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting State
- What is being tested?
- Carvedilol Tablets USP 12.5 mg and Carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Nov 2011
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female human subjects, age in the range of 18 - 45 years.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).
- Willingness to follow the protocol requirements as evidenced by written informed consent.
- Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.
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- No history of drug abuse in the past one year.
- Non-smokers and non-alcoholics.
- For female subject is child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies,Diaphragm, Intrauterine device and Abstinence.
- OR
- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).
Who cannot join
- Known history of hypersensitivity to Carvedilol, 4-hydroxyphenyl-carvedilol or related drugs.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- 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, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
- Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
- History of malignancy or other serious diseases.
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- Refusal to abstain from food for at least ten (10) hours prior to study drug administration and for at least four (04) hours post-dose, in each study period.
- Any contraindication to blood sampling or difficulty in accessibility of veins.
- Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.
- Refusal to avoid the use of xanthine-containing food or beverages (chocolates,tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.
- Blood donation within 90 days prior to the commencement of the study.
- Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.
- Found positive in breath alcohol test done before check-in for each study period.
- Found positive in urine test for drugs of abuse done before check-in for each study period.
- Refusal to abstain from consumption of tobacco products 24 hours prior to dosing until the last blood sample collection of last study period.
- History of problem in swallowing Tablets.
- Female subject, demonstrating positive urine pregnancy test at the time of screening.
- Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.
- Female subject, currently breast feeding or lactating.
- Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Carvedilol Tablets USP 12.5 mg With Coreg® 12.5 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.
Read the detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Carvedilol Tablets USP 12.5 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Coreg® (Carvedilol Tablets) 12.5 mg Tablets of M/s GlaxoSmithKline, under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.
The study was conducted with 42 healthy adult subjects. In each study period, a single 12.5 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
- Conditions
- Fasting State
- Being tested
- Carvedilol Tablets USP 12.5 mg, Carvedilol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol Tablets USP 12.5 mgDrug
Also called Test Product
12.5mg tablet once a day
CarvedilolDrug
Also called Coreg®
12.5mg tablet once a day
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol Tablets USP 12.5 mg | Experimental | Carvedilol Tablets USP 12.5 mg of M/s Ipca Laboratories Limited, India Receives: Drug: Carvedilol Tablets USP 12.5 mg |
| Coreg® | Active comparator | Coreg® (Carvedilol Tablets) 12.5 mg of M/s GlaxoSmithKline Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence is based on Cmax and AUC parameters.Sampling Hours: Pre-dose and at 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.
Bioequivalence was concluded if:
The 90% confidence interval of geometric mean ratio of Cmax, AUC0-t and AUC0-inf between test and reference product fall within the range of 80.00 % to 125.00 % for Carvedilol.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting StateStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPCA Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Tarang Shah, M.D., Principal investigator, Accutest Research Lab (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577914
- Sponsor's protocol ID
- Ipca/ARL/203
- Status last verified
- Jul 2012
- First submitted
- 12 Apr 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Carvedilol Tablets USP 12.5 mg With Coreg® 12.5 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT01577914
- Acronym / sponsor ID
- Ipca/ARL/203
- Conditions
- Fasting State
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- IPCA Laboratories Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Apr 2012 (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.
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human subjects.
Detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Carvedilol Tablets USP 12.5 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Coreg® (Carvedilol Tablets) 12.5 mg Tablets of M/s GlaxoSmithKline, under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.
The study was conducted with 42 healthy adult subjects. In each study period, a single 12.5 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol Tablets USP 12.5 mg | Experimental | Drug: Carvedilol Tablets USP 12.5 mgCarvedilol Tablets USP 12.5 mg of M/s Ipca Laboratories Limited, India |
| Coreg® | Active comparator | Drug: CarvedilolCoreg® (Carvedilol Tablets) 12.5 mg of M/s GlaxoSmithKline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female human subjects, age in the range of 18 - 45 years.
- Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).
- Willingness to follow the protocol requirements as evidenced by written informed consent.
Key exclusion criteria (20 listed)
- Known history of hypersensitivity to Carvedilol, 4-hydroxyphenyl-carvedilol or related drugs.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- 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, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
- Participation in a clinical drug study or bioequivalence study within 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 |
|---|---|---|
| Carvedilol Tablets USP 12.5 mgAlso: Test Product12.5mg tablet once a day | Drug | Carvedilol Tablets USP 12.5 mg |
| CarvedilolAlso: Coreg®12.5mg tablet once a day | Drug | Coreg® |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.Sampling Hours: Pre-dose and at 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.
Time frame: 5 months
Bioequivalence was concluded if: The 90% confidence interval of geometric mean ratio of Cmax, AUC0-t and AUC0-inf between test and reference product fall within the range of 80.00 % to 125.00 % for Carvedilol.
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 9 Jul 2012.
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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. Tarang Shah, M.D. principal investigator
Accutest Research Lab (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 Phase 1 study testing Carvedilol Tablets USP 12.5 mg and Carvedilol in people with Fasting State, run by IPCA Laboratories 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 11 inclusion and 20 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 9 Jul 2012. 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.
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?
Bioequivalence is based on Cmax and AUC parameters.Sampling Hours: Pre-dose and at 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose. (time frame: 5 months). 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 9 Jul 2012.