title: Evaluation of a Pharmacokinetic Interaction between Telmisartan and Chlorthalidone in Healthy Male Adult Subjects.
abstract: OBJECTIVE
  Combination therapy is recommended for the effective management of hypertension according to most treatment guidelines, including those of the US Joint National Committee. Therefore, pharmacokinetic drug interactions are an important issue in combination therapy for hypertension. In this study, the pharmacokinetic properties of telmisartan and chlorthalidone were evaluated to investigate their pharmacokinetic interactions in healthy subjects.
  
  
  METHODS
  Two separate, randomized, multiple-dose, two-period, one-sequence studies were conducted. In study A, 43 participants received 80 mg of telmisartan orally for 7 days, and were then administered oral chlorthalidone 25 mg for 14 days (days 8-21), coadministered with 80 mg of telmisartan from day 15. In study B, 14 participants received oral chlorthalidone (25 mg) for 13 days, followed by coadministration with 80 mg of telmisartan orally for 7 days.
  
  
  RESULTS
  The geometric mean ratios (GMRs) (90 % confidence intervals [CIs]) of the maximum plasma concentration (C max,ss) and area under the concentration-time curve for the dosing interval at steady state (AUCτ,ss) of telmisartan (with and without chlorthalidone) were 1.018 (0.861-1.203) and 1.099 (1.015-1.190), respectively. For chlorthalidone (with/without telmisartan), the GMRs (90 % CIs) for C max,ss and AUCτ,ss were 0.996 (0.922-1.075) and 0.992 (0.925-1.064), respectively. The GMRs and 90 % CIs for telmisartan and chlorthalidone were all within the 0.80-1.25 range.
  
  
  CONCLUSIONS
  Thus, in this study, there was no significant pharmacokinetic interaction between telmisartan and chlorthalidone. CLINICALTRIAL.
  NCT01806363.
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea.
authors.forename: Sook Jin
authors.initials: SJ
authors.lastname: Seong
authors.affiliation: College of Pharmacy, Yeungnam University, Kyungsan, Kyungpook, Republic of Korea.
authors.forename: Mi-Sun
authors.initials: MS
authors.lastname: Lim
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea.
authors.forename: Joomi
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea.
authors.forename: Boram
authors.initials: B
authors.lastname: Ohk
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea.
authors.forename: Mi-Ri
authors.initials: MR
authors.lastname: Gwon
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea.
authors.forename: Bo Kyung
authors.initials: BK
authors.lastname: Kim
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea.
authors.forename: Hyun-Ju
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors.forename: Dong Heon
authors.initials: DH
authors.lastname: Yang
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea.
authors.forename: Hae Won
authors.initials: HW
authors.lastname: Lee
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea.
authors.forename: Woo Youl
authors.initials: WY
authors.lastname: Kang
authors.affiliation: Department of Biomedical Science, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Cell and Matrix Research Institute and Clinical Trial Center, Kyungpook National University Graduate School and Hospital, Daegu, Republic of Korea. yry@knu.ac.kr.
authors.forename: Young-Ran
authors.initials: YR
authors.lastname: Yoon
mesh_terms: D000328:Adult; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000493:pharmacokinetics*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001562:Benzimidazoles / Q000009:adverse effects / Q000493:pharmacokinetics*; D001565:Benzoates / Q000009:adverse effects / Q000493:pharmacokinetics*; D002752:Chlorthalidone / Q000009:adverse effects / Q000493:pharmacokinetics*; D004232:Diuretics / Q000009:adverse effects / Q000493:pharmacokinetics*; D004347:Drug Interactions; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077333:Telmisartan; D055815:Young Adult
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001565:Benzoates; D004232:Diuretics; D002752:Chlorthalidone; D000077333:Telmisartan