Fasting StatePhase 1NCT01618799
Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition
A Phase 1 study testing Lamotrigine Tablets 25 mg and Lamotrigine in people with Fasting State, run by IPCA Laboratories Ltd. at 1 site in India.
Trial summary
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in 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?
- Lamotrigine Tablets 25 mg and Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2012to May 2012
- 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
- Age: 18 to 45 years old, both inclusive.
- Sex: Males and/or non-pregnant, non-lactating females.
- Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to initiation of the study \& prior to check-in of each period. They must be using an acceptable form of contraception.
- Acceptable forms of contraception include the following:
- Intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- Barrier methods containing or used in conjunction with a spermicidal agent, or
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- Surgical sterilization or
- Practicing sexual abstinence throughout the course of the study.
- Females will not be considered of childbearing potential if one one of the following is reported and documented on the medical history:
- Postmenopausal with spontaneous amenorrhea for at least one year, or
- Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- Total hysterectomy and an absence of bleeding for at least 3 months.
- BMI: 18.5 to 24.9 weight in Kg / (height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 24.94 rounds down to 24.9. while 18.45 rounds up to 18.5).
- Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
- Able to give written informed consent to participate in the study.
- All volunteers must be judged by the principal or co-investigator or physician as normal and healthy during pre-study safety assessment performed within 21 days of the first dose of study medication which will include:
- A physical examination with no clinically significant finding.
- Results within normal limits or clinically non-significant for the tests mentioned in list of Laboratory Parameters:
- Additional tests and/or examinations may be performed, if necessary, based on Principal Investigator discretion.
- All results will be assessed against the laboratory normal ranges current at the time of testing and a copy of the normal ranges used will be included in the study documentation.
Who cannot join
- History of allergic responses to Lamotrigine or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers) \& transvaginal ultrasonography (for female volunteers)].
- Any disease or condition which might compromise the haemopoeitic gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to study medication dosing.
- A depot injection or implant of any drug within 3 months prior to administration of study medication.
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- Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- History of allergic response to heparin.
- A positive hepatitis screen (includes subtypes B \& C).
- A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- Volunteers who have donated blood (1 unit or 450 ml) within 90 days prior to the initial dose of the study drug or have blood loss, excluding volume drawn at screening for this study drug.
- History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption.
- Intolerance to venipuncture.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator, could contraindicate the volunteer's participation in this study.
- Volunteers who have received a known investigational drug within five elimination half life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to initial dose of study drug, whichever is greater.
- Found positive in urine test for drugs of abuse done before check-in of period I.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Lamotrigine Tablets 25 mg (2 × 25 mg Tablets) and 'LAMICTAL®' (Lamotrigine) Tablets 25 mg (2 × 25 mg Tablets) in Healthy Adult Human Subjects Under Fasting Conditions.
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.
Read the detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Lamotrigine Tablets 25 mg (2 x 25 mg)of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: LAMICTAL® (Lamotrigine) Tablets 25 mg (2 x 25 mg) of GlaxoSmithkline, USA, under fasting condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 28 healthy adult subjects. In each study period, a single 2 X 25 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 26 days including washout period of at least 21 days between administrations of study drug in each study period.
- Conditions
- Fasting State
- Being tested
- Lamotrigine Tablets 25 mg, Lamotrigine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine Tablets 25 mgDrug
Also called Test Product
2 x 25 mg tablet once a day
LamotrigineDrug
Also called LAMICTAL®
2 x 25 mg tablet once a day
| Study group | Role | What they receive |
|---|---|---|
| LAMICTAL® | Active comparator | Lamictal® (Lamotrigine) Tablets 25 mg of GlaxoSmithkline, USA Receives: Drug: Lamotrigine |
| Lamotrigine Tablets 25 mg | Experimental | Lamotrigine Tablets 25 mg of M/s Ipca Laboratories Limited, India Receives: Drug: Lamotrigine Tablets 25 mg |
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.
Area Under Curve (AUC)and Cmax Sampling Hours: Pre-dose and at 00.25, 00.5, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 03.25, 03.50, 04.00, 04.25, 05.00, 06.00, 08.00, 10.00, 12.00, 18.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPCA Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Manish Singhal, MBBS, Principal investigator, Cliantha Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618799
- Sponsor's protocol ID
- Ipca/BA/1264033
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Lamotrigine Tablets 25 mg (2 × 25 mg Tablets) and 'LAMICTAL®' (Lamotrigine) Tablets 25 mg (2 × 25 mg Tablets) in Healthy Adult Human Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01618799
- Acronym / sponsor ID
- Ipca/BA/1264033
- Conditions
- Fasting State
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- IPCA Laboratories Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Jun 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 an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.
Detailed description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Lamotrigine Tablets 25 mg (2 x 25 mg)of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: LAMICTAL® (Lamotrigine) Tablets 25 mg (2 x 25 mg) of GlaxoSmithkline, USA, under fasting condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 28 healthy adult subjects. In each study period, a single 2 X 25 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 26 days including washout period of at least 21 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 |
|---|---|---|
| LAMICTAL® | Active comparator | Drug: LamotrigineLamictal® (Lamotrigine) Tablets 25 mg of GlaxoSmithkline, USA |
| Lamotrigine Tablets 25 mg | Experimental | Drug: Lamotrigine Tablets 25 mgLamotrigine Tablets 25 mg of M/s Ipca Laboratories Limited, India |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Age: 18 to 45 years old, both inclusive.
- Sex: Males and/or non-pregnant, non-lactating females.
- BMI: 18.5 to 24.9 weight in Kg / (height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 24.94 rounds down to 24.9. while 18.45 rounds up to 18.5).
- Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
- Able to give written informed consent to participate in the study.
Key exclusion criteria (19 listed)
- History of allergic responses to Lamotrigine or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers) \& transvaginal ultrasonography (for female volunteers)].
- Any disease or condition which might compromise the haemopoeitic gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to study medication dosing.
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 |
|---|---|---|
| Lamotrigine Tablets 25 mgAlso: Test Product2 x 25 mg tablet once a day | Drug | Lamotrigine Tablets 25 mg |
| LamotrigineAlso: LAMICTAL®2 x 25 mg tablet once a day | Drug | LAMICTAL® |
Primary outcome
Bioequivalence is based on Cmax and AUC parameters.
Time frame: 3 months
Area Under Curve (AUC)and Cmax Sampling Hours: Pre-dose and at 00.25, 00.5, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 03.25, 03.50, 04.00, 04.25, 05.00, 06.00, 08.00, 10.00, 12.00, 18.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose.
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 13 Jun 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. Manish Singhal, MBBS principal investigator
Cliantha Research Limited
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 Lamotrigine Tablets 25 mg and Lamotrigine 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 20 inclusion and 19 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 13 Jun 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. (time frame: 3 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 13 Jun 2012.