Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions

NCT06297174 | Not Yet Recruiting Phase 1

• 1 other identifier: BE23-035
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Vollunteer

Keywords

Racecadotril; Bioequivalence 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 Capsules; Drug: HIDRASEC®

HIDRASEC®

ACTIVE COMPARATOR

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

Drug: Racecadotril 100 mg Capsules; Drug: HIDRASEC®

Interventions

Racecadotril 100 mg Capsules DRUG

Racecadotril 100 mg Capsules (test drug)

Generic Racecadotril 100 mg Capsules; HIDRASEC®

HIDRASEC® DRUG

HIDRASEC® (reference drug)

Also known as: Racecadotril 100 mg Capsules

Generic Racecadotril 100 mg Capsules; HIDRASEC®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• 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.

Sponsors & Collaborators

• Pharma Nueva: lead

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; thanaporn.won@mahidol.ac.th

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
• Primary Completion: September 17, 2024
• Study Completion: September 20, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share