Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject

NCT04988646 | Completed Results DMC

• 1 other identifier: 515/STD/PML/2019
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this present study was to asses the pharmacokinetic properties of acyclovir tablet from new product formulation (PT. Kimia Farma (Persero) Tbk) to its innovator product, Zovirax® tablet (Glaxo Wellcome S.A., Aranda, Spain)

Conditions

Drug Use

Keywords

bioequivalence; pharmacokinetics; Indonesian healthy subject; Acyclovir

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics Parameter

  Maximum plasma concentration (Cmax)

  before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing

• Pharmacokinetics Parameter

  Area Under Curve from 0 to 24 hours (AUCt)

  Predose at (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose

Secondary Outcomes (2)

• Geometric Mean Ratio

  before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing

• Geometric Mean Ratio

  before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing

Study Arms (2)

Acyclovir Tablet

EXPERIMENTAL

Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water

Drug: Acyclovir 200 MG; Drug: Acyclovir 400 MG

Zovirax® Tablet

ACTIVE COMPARATOR

Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water

Drug: Zovirax 200 MG Tablet; Drug: Zovirax 400 MG Tablet

Interventions

Acyclovir 200 MG DRUG

Administered with 240 mL of water

Acyclovir Tablet

Acyclovir 400 MG DRUG

Administered with 240 mL of water

Acyclovir Tablet

Zovirax 200 MG Tablet DRUG

Administered with 240 mL of water

Zovirax® Tablet

Zovirax 400 MG Tablet DRUG

Administered with 240 mL of water

Zovirax® Tablet

Eligibility Criteria

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

You may qualify if:

• body weight within normal range (body mass index between 18 and 25 kg/m2)
• had normal blood pressure (systolic was ranged between 90 to 120 mmHg and diastolic was ranged between 60 to 80 mmHg)
• had normal electrocardiogram
• absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

You may not qualify if:

• pregnant women
• nursing mothers
• women of childbearing potential without adequate contraception
• had a history of contraindication or hypersensitivity to aciclovir, or other antiviral or other ingredients in the study products or a history of serious allergic reaction to any drug,
• a significant allergic disease, or allergic reaction; presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease
• presence of any coagulation disorder or clinically significant hematology abnormalities; using any medication (prescription or non-prescription drug, food supplement, herbal medicine)
• particularly the medication known to affect the pharmacokinetics of the study drug
• who had participated in any clinical study within 3 months prior to the study (\< 90 days)
• subjects who had donated or lost 300 ml (or more) of blood within 3 months prior to the study
• who were positive to HIV, HBsAg, and HCV tests
• who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits
• poor venous access; and who smoked more than 10 cigarettes a day
• had a history of drug or alcohol abuse within 12 months prior to screening for this study and who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access

Sponsors & Collaborators

• PT. Kimia Farma (Persero) Tbk: lead
• PT Pharma Metric Labs: collaborator

Study Sites (1)

PT Pharma Metric Labs

Jakarta Pusat, DKI Jakarta, 10520, Indonesia

Location

Related Publications (13)

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  PMID: 29146146 RESULT

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• Vaithianathan S, Haidar SH, Zhang X, Jiang W, Avon C, Dowling TC, Shao C, Kane M, Hoag SW, Flasar MH, Ting TY, Polli JE. Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir. J Pharm Sci. 2016 Feb;105(2):996-1005. doi: 10.1002/jps.24643. Epub 2016 Jan 12.

  PMID: 26375604 RESULT

• de Miranda P, Blum MR. Pharmacokinetics of acyclovir after intravenous and oral administration. J Antimicrob Chemother. 1983 Sep;12 Suppl B:29-37. doi: 10.1093/jac/12.suppl_b.29.

  PMID: 6355048 RESULT

• O'Brien JJ, Campoli-Richards DM. Acyclovir. An updated review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy. Drugs. 1989 Mar;37(3):233-309. doi: 10.2165/00003495-198937030-00002.

  PMID: 2653790 RESULT

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  PMID: 9587049 RESULT

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  PMID: 18081360 RESULT

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  PMID: 8275615 RESULT

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  PMID: 25473327 RESULT

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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

Results Point of Contact

• Title: Pharma Metric Labs
• Organization: Pharma Metric Labs, Indonesia

nabila.sutanto@pharmametriclabs.com

+62 21 4265310

Study Officials

• Metta Sinta Sari Wiria

  PT Pharma Metric Labs

  PRINCIPAL INVESTIGATOR

• I Gusti Putu Bagus Diana Virgo

  PT Pharma Metric Labs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single blind, single dose, 2-periods, cross-over design study with one week washout period between each treatment in 28 healthy subjects under fasting condition

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 3, 2021
• Study Start: February 21, 2020
• Primary Completion: April 20, 2020
• Study Completion: April 28, 2020
• Last Updated: February 9, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-02

Locations

ID (1)