Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers

NCT06308068 | Not Yet Recruiting Phase 1

• 1 other identifier: BE24-002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 fed conditions

Conditions

Healthy Volunteer

Keywords

Diacerein 50 mg Capsule

Outcome Measures

Primary Outcomes (2)

• Bioequivalence based on Cmax period

  Bioequivalence based on Cmax period

  Through 36 Hours Post Dose]

• Bioequivalence based on AUC parameters

  Bioequivalence based on AUC parameters

  Through 36 Hours Post Dose]

Study Arms (2)

Generic diacerein 50 mg capsule

EXPERIMENTAL

Each subject will receive a single dose of generic diacerein 50 mg capsule, EIDAR, as a test formulation (T), or a single dose of diacerein 50 mg capsule, with 240±2 mL of ambient temperature drinking water at 30 minutes after the start of standardized HFHC breakfast. Investigational product will be provided to subject in stainless steel cup and subject will be dosed without touching the tablet. 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.

Drug: Diacerein 50 mg Capsule

Diacerein 50 mg capsule, ARTRODAR®

ACTIVE COMPARATOR

Each subject will receive a single dose of generic diacerein 50 mg capsule, , ARTRODAR®, as a reference formulation (R), with 240±2 mL of ambient temperature drinking water at 30 minutes after the start of standardized HFHC breakfast. Investigational product will be provided to subject in stainless steel cup and subject will be dosed without touching the tablet. 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

Drug: Diacerein 50 mg Capsule

Interventions

Diacerein 50 mg Capsule DRUG

Diacerein 50 mg Capsule

Also known as: Diacerein

Diacerein 50 mg capsule, ARTRODAR®; Generic diacerein 50 mg capsule

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 2. 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 2.
• 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 diacerein or rhein or anthraquinone derivatives or to any of the excipients
• History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric, neurologic (e.g. seizures), 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 enterocolic disturbances such as irritable colon
• History or evidence of inflammatory intestinal disease (e.g. ulcerative colitis, Crohn's disease), intestinal obstruction or pseudo-obstruction, painful abdominal syndromes of undetermined cause
• History or evidence of severe liver disease
• History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• History of problems with swallowing tablet or capsule
• Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
• History of diarrhea or vomiting or dehydration 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 level of potassium less than 3.5 or more than 5.0 mmol/L at screening laboratory test.
• Have eGFR (CKD-EPI) \< 50 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

diacerein

Study Officials

• Porranee Puranajoti, Ph. D

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweena Boonprakong

CONTACT

024415211; paweena.bon@mahidol.ac.th

Thanaporn Wongyai, B.Sc.Pharm

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: July 30, 2024
• Primary Completion: August 3, 2024
• Study Completion: August 18, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share