NCT06297174

UnknownPhase 1

Bioequivalence Study of Generic Racecadotril 100 mg Capsules...

Pharma Nueva Source

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Other study identifiers

Sponsor study identifier

BE23-035

Study Type

interventional

Estimated enrollment

44

Locations

0 countries

Sites

N/A

Timeline

Study Start

August 26, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

September 17, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 20, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief 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 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 44 participants
Study completion date: September 20, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 29, 2024
Actual (reported)
First Posted
March 7, 2024
Actual (reported)
Study Start
August 26, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 17, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 20, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: March 7, 2024
Status Verified: February 2024
Last Update Submitted: February 29, 2024

Conditions

Healthy Vollunteer

Keywords

RacecadotrilBioequivalence study

Outcome Measures

Primary Outcomes (2)

Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril
Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril
Through 36 hours post dose
Peak Plasma Concentration (Cmax) of Racecadotril
Peak Plasma Concentration (Cmax) of Racecadotril
36 hours post dose

Study Arms (2)

Generic Racecadotril 100 mg Capsules

EXPERIMENTAL

Generic Racecadotril 100 mg Capsules (test drug)

Drug: Racecadotril 100 mg CapsulesDrug: HIDRASEC®

HIDRASEC®

ACTIVE COMPARATOR

HIDRASEC® (Racecadotril 100 mg Capsules (reference drug))

Drug: Racecadotril 100 mg CapsulesDrug: HIDRASEC®

Interventions

Racecadotril 100 mg CapsulesDrug

Racecadotril 100 mg Capsules (test drug)

Generic Racecadotril 100 mg CapsulesHIDRASEC®

HIDRASEC®Drug

HIDRASEC® (reference drug)

Also known as: Racecadotril 100 mg Capsules

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Pharma Nueva
Industrylead

MeSH Terms

Interventions

racecadotril

Study Officials

Porranee Puranajoti
International Bio service
PRINCIPAL INVESTIGATOR

Central Study Contacts

Aksorn Jarupintusopon

CONTACT

0918744146 aksorn.riengsilchai@pharmanueva.com

Thanaporn Wongyai

CONTACT

024415211

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 7, 2024

Study Start

August 26, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

September 17, 2024

NCT01476683

Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products

Phase 1Completed

NCT05216822

Anti-Secretory Drug in Treatment of Acute Watery Diarrhea

Phase 1Completed

NCT06529497

Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children

Phase 1/2Completed

NCT07392931

Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea

Not ApplicableCompleted

NCT01302093

Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults

Phase 1Completed

NCT01577043

Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Phase 4Completed

Generic Racecadotril 100 mg Capsules

HIDRASEC®

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:

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

You may not qualify if:

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.
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.
+13 more criteria

Contact the study team to confirm eligibility.

thanaporn.won@mahidol.ac.th

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 20, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

March 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06297174
Data provider: ClinicalTrials.gov
Source updated: 2024-03-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:09 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Generic Racecadotril 100 mg Capsules

HIDRASEC®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record