Bioequivalence Study of Amlodipine/Valsartan 10/160 mg Film Coated Tablets

NCT06193044 | Unknown Phase 1

• 1 other identifier: BE22-041
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparative randomized, Single dose, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets and Exforge10/160 mg film coated tablets (Novartis Pharma, USA).

Conditions

Healthy Volunteer

Keywords

Amlodipine; Valsartan

Outcome Measures

Primary Outcomes (2)

• Bioequivalence based on Cmax period

  Bioequivalence based on Cmax period

  Up to 72 hours post dose in each treatment

• Bioequivalence based on AUC parameters

  Bioequivalence based on AUC parameters

  Up to 72 hours post dose in each treatment

Study Arms (2)

Amlodipine and Valsartan Tablets USP 10/160 mg, Then Exforge® 10/160 mg

EXPERIMENTAL

Participants first received Amlodipine and Valsartan Tablet USP 10/160 mg 1 tablet (Test product) in a fasting state.After a washout period of 21 days, they then recieved Exforge® 10/160 mg tablet (Reference product) in a fasting state

Drug: Amlodipine/Valsartan; Drug: Amlodipine 10 mg &valsartan 160 mg (Exforge)

Exforge® 10/160 mg, Then Amlodipine and Valsartan Tablets USP 10/160 mg

ACTIVE COMPARATOR

Participants first received Exforge® 10/160 mg tablet 1 tablet (Reference product) in a fasting state.After a washout period of 21 days, they then recieved Amlodipine and Valsartan Tablets USP 10/160 mg (Test product) in a fasting state.

Drug: Amlodipine/Valsartan; Drug: Amlodipine 10 mg &valsartan 160 mg (Exforge)

Interventions

Amlodipine/Valsartan DRUG

Amlodipine 10 mg \&valsartan 160 mg

Also known as: Amlodipine / Valsartan

Amlodipine and Valsartan Tablets USP 10/160 mg, Then Exforge® 10/160 mg; Exforge® 10/160 mg, Then Amlodipine and Valsartan Tablets USP 10/160 mg

Amlodipine 10 mg &valsartan 160 mg (Exforge) DRUG

Amlodipine 10 mg \&valsartan 160 mg

Also known as: Exforge

Amlodipine and Valsartan Tablets USP 10/160 mg, Then Exforge® 10/160 mg; Exforge® 10/160 mg, Then Amlodipine and Valsartan Tablets USP 10/160 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 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period 1.
• 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-smoker and non-consumer of nicotine containing products Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked/consumed or stopped for at least 90 days.
• 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 14 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 14 days after the end of study in Period 4.
• Able to understand and voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
• Adequate venous access in both arms for the collection of a number of samples during the 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

Amlodipine, Valsartan Drug Combination; Amlodipine; Valsartan

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Porranee Puranajoti, Prof.

  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

Model Details: (Reference Replicate)

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: May 7, 2024
• Primary Completion: July 9, 2024
• Study Completion: July 12, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share