Bioequivalence study of pregabalin 25 mg capsule in Thai healthy volunteers

Phase 4

• Conditions: - Thai healthy male and female subjects- Aged 18 †50 years - BMI were within 18- 25 kg/m2- Good health confirming by physical and clinica; bioequivalence, pharmacokinetic, pregabalin

• Registration Number: TCTR20161117001
• Lead Sponsor: Ratchadapisek Sompoj Fund, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-17
• Study Completion: 2017-03-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Subjects who are Thai male or female, aged 18 to 50 years.
2. Subjects whose BMI is 18-25 kg/m2.
3. Subjects who are healthy by medical history, physical examination and vital signs.
4. Subject whose screening visit laboratory values of blood tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, albumin, electrolytes are within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator. Hepatitis Bs-antigen and anti-HIV are negative.
5. For female subjects:
Female subject who is in childbearing potential must have serum β-HCG negative and agrees to use an acceptable birth control method from visit 1 to the last visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD) and diaphragm with spermicial agent) or total abstinence from sexual intercourse from visit 1 to the last visit. Hormonal contraceptives are not acceptable.
Female subject who is in child bearing potential must agree not to become pregnant for the entire participation phase and must have a negative result for urine pregnancy test performing prior to dosing at phase I and II.
Female subjects can be those with non-childbearing potential which defined as female subjects with hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea).
6. Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria

1. Subjects who are with a history/evidence of allergy or hypersensitivity to pregabalin or any related drug.
2. Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of the study or pose an additional risk in administrating study drug to the subjects. This may include but not limited to: a history of relevant drug or food allergies; history or cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
3. Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least one day before the study and until the completion of the study phase.
4. Subjects who are with a history of alcoholic (more than 2 years) or moderate drinkers (more than 3 drinks per day †one is equal to one unit of alcohol: - one glass of wine, half pine of beer or one measure of spirit) or subjects who are with a history of any drug abuse.
5. Subjects who receive of any medical prescription within 14 days before the first administration of the study drug, especially drug related to the study drug metabolizing enzyme.
6. Female subjects who are pregnant or breast feeding.
7. Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 month prior to the screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bioequivalence of test and reference products, pregabalin 25 mg capsule 4 months The 90% confidence interval (two one-sided tests) for the differences of Cmax, AUC0-t and AUC0-inf m

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic of pregabalin 25 mg capsule in Thai healthy volunteers 4 months pharmacokinetic parameters