Healthy VollunteerPhase 1NCT06297174
Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions
A Phase 1 study testing Racecadotril 100 mg Capsules and HIDRASEC® in people with Healthy Vollunteer, run by Pharma Nueva.
Trial summary
Objectives: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions Study Design: An open label, randomized, two-treatment, four-period, two-sequence, replicate… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Vollunteer
- What is being tested?
- Racecadotril 100 mg Capsules and HIDRASEC®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2024to 20 Sep 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Thai male or female subjects between the ages of 18 to 55 years.
- Body mass index between 18.5 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 4. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
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- Postmenopausal for at least 1 year or
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
- Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 4.
- Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
Who cannot join
- History of allergic reaction or hypersensitivity to the active substance or to any of the excipients.
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness.
- Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19.
- History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
- History or evidence of angioedema.
- History of febrile illness within 7 days prior to check-in in each period.
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- History or evidence of antibiotic-associated colitis such as pseudomembranous colitis.
- History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- History of problems with swallowing tablet or capsule.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy.
- History of diarrhea, dehydration or vomiting within 24 hours prior to check-in in each period.
- History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine).
- Investigation with blood sample shows positive test for HBsAg.
- Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test.
- History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study.
- History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.).
- History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result.
- In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject's eligibility which must be 0 mg%BAC.
- History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study.
- Consume or drink juice of grapefruit or orange or pomelo or its supplement/containing products and cannot abstain for at least 7 days prior to check-in in Period 1 and continued for entire duration of the study.
- Use of prescription or nonprescription drugs (e.g. paracetamol, ACE inhibitors, other drug that can induced angioedema such as angiotensin II receptor blockers, direct renin inhibitors, betalactam antibiotics and other non-steroidal anti-inflammatory drugs (NSAIDs), etc.), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to check-in in Period 1 and continued for entire duration of the study.
- Participated in other clinical trials within 90 days prior to check-in in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study.
- Blood donation or blood loss ≥ 1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to check-in in Period 1 or during enrollment.
- Subjects with poor venous access or intolerant to venipuncture.
- Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study.
- Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team.
- Subjects who are employees of International Bio Service Co., Ltd., Pharma Nueva Co., Ltd. or Siam Pharmaceutical Co., Ltd.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Racecadotril 100 mg Capsules and Reference Product (HIDRASEC®) in Healthy Thai Volunteers Under Fasting Conditions
Objectives:
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions
Study Design:
An open label, randomized, two-treatment, four-period, two-sequence, replicate crossover bioequivalence study in healthy Thai volunteers under fasting conditions with at least 7 days washout period between the administrations of investigational products of each period
Read the detailed description
Each subject will receive a single dose of racecadotril 100 mg capsules, as a test formulation (T) or a single dose of racecadotril 100 mg capsules, HIDRASEC, as a reference formulation (R), with 240±2 mL of ambient temperature drinking water after an overnight fasting for at least 10 hours. Investigational product will be provided to subject in stainless steel cup and subject will be dosed without touching the capsule. This activity will be followed by a mouth check using a tongue depressor and a flashlight to assess the compliance of dosing. The formulations will be given in a crossover fashion as per the randomization schedule. The dosing processes will be conducted under normal light condition.
In each period, total of 23 blood samples will be collected from 23 sampling time points. Blood samples (3.5 mL each) will be collected at time 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00 and 36.00 hours post-dose.
- Conditions
- Healthy Vollunteer
- Being tested
- Racecadotril 100 mg Capsules, HIDRASEC®
- Keywords
- Racecadotril, Bioequivalence study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racecadotril 100 mg CapsulesDrug
Racecadotril 100 mg Capsules (test drug)
HIDRASEC®Drug
Also called Racecadotril 100 mg Capsules
HIDRASEC® (reference drug)
| Study group | Role | What they receive |
|---|---|---|
| Generic Racecadotril 100 mg Capsules | Experimental | Generic Racecadotril 100 mg Capsules (test drug) Receives: Drug: Racecadotril 100 mg Capsules; Drug: HIDRASEC® |
| HIDRASEC® | Active comparator | HIDRASEC® (Racecadotril 100 mg Capsules (reference drug)) Receives: Drug: Racecadotril 100 mg Capsules; Drug: HIDRASEC® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril
Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril
Measured: Through 36 hours post dose
Peak Plasma Concentration (Cmax) of Racecadotril
Peak Plasma Concentration (Cmax) of Racecadotril
Measured: 36 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start26 Aug 2024 (estimated)
- Primary completion17 Sep 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VollunteerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharma Nueva
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Porranee Puranajoti, Principal investigator, International Bio service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297174
- Sponsor's protocol ID
- BE23-035
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Racecadotril 100 mg Capsules and Reference Product (HIDRASEC®) in Healthy Thai Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06297174
- Acronym / sponsor ID
- BE23-035
- Conditions
- Healthy Vollunteer
- Keywords
- Racecadotril, Bioequivalence study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Pharma NuevaIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (estimated)
- Primary completion
- 17 Sep 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 7 Mar 2024 (actual)
- 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.
Objectives:
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions
Study Design:
An open label, randomized, two-treatment, four-period, two-sequence, replicate crossover bioequivalence study in healthy Thai volunteers under fasting conditions with at least 7 days washout period between the administrations of investigational products of each period
Detailed description
Each subject will receive a single dose of racecadotril 100 mg capsules, as a test formulation (T) or a single dose of racecadotril 100 mg capsules, HIDRASEC, as a reference formulation (R), with 240±2 mL of ambient temperature drinking water after an overnight fasting for at least 10 hours. Investigational product will be provided to subject in stainless steel cup and subject will be dosed without touching the capsule. This activity will be followed by a mouth check using a tongue depressor and a flashlight to assess the compliance of dosing. The formulations will be given in a crossover fashion as per the randomization schedule. The dosing processes will be conducted under normal light condition.
In each period, total of 23 blood samples will be collected from 23 sampling time points. Blood samples (3.5 mL each) will be collected at time 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00 and 36.00 hours post-dose.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic Racecadotril 100 mg Capsules | Experimental | Drug: Racecadotril 100 mg Capsules, Drug: HIDRASEC®Generic Racecadotril 100 mg Capsules (test drug) |
| HIDRASEC® | Active comparator | Drug: Racecadotril 100 mg Capsules, Drug: HIDRASEC®HIDRASEC® (Racecadotril 100 mg Capsules (reference drug)) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy Thai male or female subjects between the ages of 18 to 55 years.
- Body mass index between 18.5 to 30.0 kg/m2.
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
Key exclusion criteria (28 listed)
- History of allergic reaction or hypersensitivity to the active substance or to any of the excipients.
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness.
- Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19.
- History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
- History or evidence of angioedema.
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 |
|---|---|---|
| Racecadotril 100 mg CapsulesRacecadotril 100 mg Capsules (test drug) | Drug | Generic Racecadotril 100 mg Capsules, HIDRASEC® |
| HIDRASEC®Also: Racecadotril 100 mg CapsulesHIDRASEC® (reference drug) | Drug | Generic Racecadotril 100 mg Capsules, HIDRASEC® |
Primary outcome
Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril
Time frame: Through 36 hours post dose
Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril
Peak Plasma Concentration (Cmax) of Racecadotril
Time frame: 36 hours post dose
Peak Plasma Concentration (Cmax) of Racecadotril
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No. Confidential
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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.
Porranee Puranajoti principal investigator
International Bio service
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Racecadotril 100 mg Capsules and HIDRASEC® in people with Healthy Vollunteer, run by Pharma Nueva.
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 10 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aksorn Jarupintusopon (0918744146, aksorn.riengsilchai@pharmanueva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril (time frame: Through 36 hours post dose). The study lists 2 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 7 Mar 2024.