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

Sponsor

PT. Kimia Farma (Persero) Tbk (Industry)

Overall Status

Completed

CT.gov ID

NCT04988646

Collaborator

PT Pharma Metric Labs (Industry)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

25.4

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Drug Use	Drug: Acyclovir 200 MG Drug: Acyclovir 400 MG Drug: Zovirax 200 MG Tablet Drug: Zovirax 400 MG Tablet	N/A

Detailed Description

Twenty-eight healty subjects were given a single dose of acyclovir tablet or Zovirax® in dosage form 200 mg and 400mg with 240 mL of water. Then the blood samples for acyclovir was drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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 conditionRandomized, 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

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Pharmacokinetic Properties of Acyclovir

Actual Study Start Date :

Feb 21, 2020

Actual Primary Completion Date :

Apr 20, 2020

Actual Study Completion Date :

Apr 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acyclovir Tablet Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water	Drug: Acyclovir 200 MG Administered with 240 mL of water Drug: Acyclovir 400 MG Administered with 240 mL of water
Active Comparator: Zovirax® Tablet Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water	Drug: Zovirax 200 MG Tablet Administered with 240 mL of water Drug: Zovirax 400 MG Tablet Administered with 240 mL of water

Arm

Intervention/Treatment

Experimental: Acyclovir Tablet

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

Drug: Acyclovir 200 MG

Administered with 240 mL of water

Drug: Acyclovir 400 MG

Administered with 240 mL of water

Active Comparator: Zovirax® Tablet

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

Drug: Zovirax 200 MG Tablet

Administered with 240 mL of water

Drug: Zovirax 400 MG Tablet

Administered with 240 mL of water

Outcome Measures

Primary Outcome Measures

Pharmacokinetics parameter [From 0 to 24 hours]
Maximum plasma concentration (Cmax)
Pharmacokinetics parameter [Predose at (0 h) and 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose]
Area Under Curve from 0 to 24 hours (AUCt)

Secondary Outcome Measures

Geometric Mean Ratio [From 0 to 24 hours]
The ratio between test drug and reference drug
90% confidence intervals [From 0 to 24 hours]
The two products are considered bioequivalent when the 90% confidence intervals of the Acyclovir and Zovirax® tablet geometric mean ratio between test and reference product fall within the range of 80.00-125.00% for AUCt and Cmax

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PT Pharma Metric Labs	Jakarta Pusat	DKI Jakarta	Indonesia	10520

Sponsors and Collaborators

PT. Kimia Farma (Persero) Tbk
PT Pharma Metric Labs

Investigators

Principal Investigator: Metta Sinta Sari Wiria, PT Pharma Metric Labs
Study Director: I Gusti Putu Bagus Diana Virgo, PT Pharma Metric Labs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PT. Kimia Farma (Persero) Tbk

ClinicalTrials.gov Identifier:

NCT04988646

Other Study ID Numbers:

515/STD/PML/2019

First Posted:

Aug 3, 2021

Last Update Posted:

Aug 3, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by PT. Kimia Farma (Persero) Tbk

bioequivalence

pharmacokinetics

Indonesian healthy subject

Acyclovir

Additional relevant MeSH terms:

Acyclovir

Study Results

No Results Posted as of Aug 3, 2021