The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions

NCT06228430 | Unknown Phase 1

• 1 other identifier: BE23-028
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Acyclovir 800 mg Tablet and Reference Product (Zovirax™) in Healthy Thai Volunteers under Fasting Conditions

Conditions

Healthy Volunteer

Keywords

Bioequivalence Study; Acyclovir

Outcome Measures

Primary Outcomes (2)

• Plasma Area Under the Curve (AUC(0 to 36 Hour)) for Acyclovir

  Plasma Area Under the Curve of Acyclovir

  Through 36 Hours Post Dose

• Peak Plasma Concentration (Cmax) of Acyclovir

  Peak Plasma Concentration (Cmax) for Acyclovir

  36 Hours Post Dose

Study Arms (2)

Acyclovir 800 mg (Test Drug)

EXPERIMENTAL

Generic Acyclovir 800 mg Tablet

Drug: Acyclovir 800 mg Tablet; Drug: Zovirax™ 800 mg Tablet

ZoviraxTM 800 mg Tablet (Reference Drug)

ACTIVE COMPARATOR

ZoviraxTM 800 mg Tablet

Drug: Acyclovir 800 mg Tablet; Drug: Zovirax™ 800 mg Tablet

Interventions

Acyclovir 800 mg Tablet DRUG

Acyclovir 800 mg Tablet (Test Drug)

Also known as: Acyclovir 800 mg

Acyclovir 800 mg (Test Drug); ZoviraxTM 800 mg Tablet (Reference Drug)

Zovirax™ 800 mg Tablet DRUG

Zovirax™ 800 mg Tablet (Reference Drug)

Also known as: Acyclovir 800 mg

Acyclovir 800 mg (Test Drug); ZoviraxTM 800 mg Tablet (Reference Drug)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Thai male 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.
• 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 alfuzosin or any of the other components of this product.
• History or evidence of clinically significant renal, hepatic, gastrointestinal (e.g. intestinal occlusion), hematological, endocrine (e.g. hyper-/hypothyroid), pulmonary or respiratory (e.g. allergic rhinitis, 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.
• 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 regular faintness, dizziness, headache or postural hypotension
• History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose 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 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).
• Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and on the check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject's eligibility.
• Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per minute on screening day and on the check-in day. If abnormal pulse rate detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject's eligibility
• lead ECG demonstrating QTc \>450 msec, a 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

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

Acyclovir; Tablets

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Uthai Suvanakoot

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nannapat Wannaphruek

CONTACT

024415211; nannapat.wan@mahidol.ac.th

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: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: February 12, 2024
• Primary Completion: February 15, 2024
• Study Completion: February 22, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share