Bioequivalence Study of Simvastatin 40 mg Film-coated Tablets in Healthy Thai Volunteers

NCT06178640 | Unknown Phase 1

• 1 other identifier: BE23-041
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this bioequivalence study is to determine and compare the rate and extent of absorption and to evaluate safety of test and reference formulations. Study Design: An open label, randomized, two-treatment, four-period, two-sequence replicate crossover bioequivalence study in 46 healthy Thai volunteers under fasting conditions with at least 7 days washout period.

Conditions

Healthy Volunteer

Keywords

Simvastatin; Bioequivalence Study; Healthy Thai Volunteer

Outcome Measures

Primary Outcomes (4)

• Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid

  Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin

  Through 48 Hours Post Dose

• Peak Plasma Concentration (Cmax) of Simvastatin Acid

  Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin

  48 Hours Post Dose

• Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin

  Plasma Area Under the Curve of simvastatin

  Through 48 Hours Post Dose

• Peak Plasma Concentration (Cmax) of Simvastatin

  Peak Plasma Concentration (Cmax) of Simvastatin

  48 Hours Post Dose

Study Arms (2)

Simvastatin 40 mg, Then ZOCOR 40 mg

EXPERIMENTAL

Participants first received Simvastatin 40 mg film-coated tablet 1 tablet (Test product) in a fasting state. After a washout period of 1 week, they then recieved ZOCOR 40 mg film-coated tablet (Reference product) in a fasting state

Drug: Simvastatin 40 mg film-coated tablet; Drug: Zocor 40 mg film-coated tablet

ZOCOR 40 mg, Then Simvastatin 40 mg

ACTIVE COMPARATOR

Participants first received ZOCOR 40 mg film-coated tablet 1 tablet (Reference product) in a fasting state. After a washout period of 1 week, they then recieved Simvastatin 40 mg film-coated tablet (Test product) in a fasting state.

Drug: Simvastatin 40 mg film-coated tablet; Drug: Zocor 40 mg film-coated tablet

Interventions

Simvastatin 40 mg film-coated tablet DRUG

Simvastatin 40 mg film-coated tablet

Also known as: Simvastatin

Simvastatin 40 mg, Then ZOCOR 40 mg; ZOCOR 40 mg, Then Simvastatin 40 mg

Zocor 40 mg film-coated tablet DRUG

Zocor 40 mg film-coated tablet (Simvastatin 40 mg film-coated tablet: Reference Product)

Also known as: Simvastatin

Simvastatin 40 mg, Then ZOCOR 40 mg; ZOCOR 40 mg, Then Simvastatin 40 mg

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 - 55 years
• Body mass index between 18.5 - 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 method of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing Intrauterine Device (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 simvastatin or to any excipients of tablet
• History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
• History or evidence of muscular disease e.g. muscle pain, tenderness, weakness, myopathy or rhabdomyolysis
• Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of coronavirus disease starting in 2019 (COVID-19)
• History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period
• History of problems with swallowing tablet or capsule
• History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• 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 or vomiting within 24 hours prior to check-in in each period
• lead ECG demonstrating corrected QT interval (QTc) \>450 msec, a QRS Complex (QRS interval) \>120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
• Investigation with blood sample shows positive test for HBsAg.
• History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
• History or evidence of liver disease or renal impairment
• Creatine kinase (CK) levels \> 1.5 times of upper normal limit of reference range (unless explained by exercise) at screening laboratory test.

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Uthai Suvanakoot, Ph.D.Pharm

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nannapat Wannaphruek, Pharm.D.

CONTACT

024415211; nannapat.wan@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: December 8, 2023
• First Posted: December 21, 2023
• Study Start: August 13, 2024
• Primary Completion: August 17, 2024
• Study Completion: August 24, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share